# IVF / ART Department: Global Benchmark for Moon ERP

> Status: research input for the Moon ERP IVF department design (Egyptian/Arabic private OB/GYN and fertility centres).
> Date: 2026-10-24 · Author: research agent (web) · Scope: vendors, standards/KPIs, regional rules, commercial operations.
> Confidence legend: **[P]** primary source read directly (paper table, regulator text) · **[S]** secondary (review, news, vendor marketing) · **[I]** design inference by the author, not a sourced finding.

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## 0. Executive summary

- The mature market splits into **(a) full fertility EMRs** (MedITEX, IDEAS, eIVF, Artisan, BabySentry, ARTis), **(b) lab-safety add-ons** (RI Witness, Matcher, eWitness, TMRW/Cryogatt cryo-tracking), **(c) QA/KPI tools** (CHLOE KPI, ART Compass, IVFQC "Reflections"), and **(d) patient-experience layers** (Salve, eIVF Patient, MedITEX Hope/Connect, Embryo Options for storage billing). No single vendor does all four well. That gap is the opening for an ERP-native IVF module where billing, inventory, the LIS and the EMR already share one database.
- The **lab data model is standardised**. Istanbul consensus timings and grading (updated in 2025), Gardner blastocyst grading, the Vienna lab KPIs (19 indicators with competency and benchmark values) and the Maribor clinical KPIs (6 indicators) together define what must be captured per oocyte and per embryo, and when.
- **Traceability is the non-negotiable safety layer.** HFEA Guidance Note 18 lists 13 witnessed steps (a–m). Each check needs the full name plus 2 identifiers, a timestamp, the operator and the witness. Electronic witnessing may replace some manual checks only when it has "forcing functions", and never for mixing, injection, or freezing and thawing. Traceability data is kept at least 30 years (HFEA T103; EU 2004/23/EC).
- **Egypt runs on a closed couple model.** Treatment is for a married husband and wife using their own gametes only. Donor gametes, gamete or embryo banks and surrogacy are banned. Embryos may not be transferred after divorce, or after death except within the widow's iddah (per Dar al-Ifta). ICSI is about 92% of cycles in the registry data. A Ministry of Health draft ART law (July 2025) would add licensing and a national electronic case database. Its status since then is unknown.
- **Revenue in practice** comes from a cycle package (OPU + ICSI + ET), plus separately billed drugs, freezing and **recurring storage fees** with consent renewal. Storage billing tied to consent status is a product category of its own (Embryo Options, Wawa, ARTis Cryo).

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## 1. Leading IVF/ART systems and their feature sets

### 1.1 Capability matrix

Key: ● = documented by the vendor or a reliable source · ◐ = partial or claimed by a third party only · — = not found (absence of evidence, not evidence of absence)

| System (vendor, origin) | Patient/couple + cycle EMR | Stim planning/monitoring | Andrology | Embryology lab sheet | Cryo inventory | Witnessing | Donor | Portal/app | Registry export | Billing/acct | KPI/QA | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| **MedITEX IVF** (CRITEX, Regensburg DE) | ● | ◐ | ● WHO params, CASA interface, calculators | ● stages, scores, AH, photos/video, PGT, time-lapse import | ● per-tank overview, straw checks | — (integrates 3rd-party) | ● donor bank, filter + link to recipient | ● Connect portal, Hope app, Survey (digital history) | ● DIR, FIVNAT, HFEA, ANZARD, RetePMA | ● MedITEX Accounting | ● MedITEX KPI | Scheduler for doctors/rooms/devices; HL7 lab import; digital consents; DocLink. Official German IVF-registry data partner. Testimonials include a UAE clinic **[P vendor site]** |
| **IDEAS** (Mellowood Medical, since 1996) | ● | ● timed orders/protocols | ● | ◐ | ◐ "ART and cryo procedure analysis" | — | ● egg/sperm donor-recipient matching | — | ◐ regulatory | ● native billing | ◐ reports | HL7, pharmacy management. Described as lab-centric and common outside the US **[S]** |
| **eIVF** (PracticeHwy, US) | ● | ● flowsheet | ● | ● | ◐ | — | ● Donor Portal (recruit, match, compliance) | ● white-label app: protocols, consents, labs, meds, messaging, appointments | ● (US/SART) | ● + Rectangle Health payments, e-Rx | ● Fertility Vision QA/QC embryology dashboard | Called the most widely deployed US fertility EMR (unverified ranking) **[S]** |
| **Artisan EMR** (Artisan Medical Solutions, US) | ● | ● | ● | ● | ◐ | — | ◐ | ◐ | ● | ● practice mgmt | ◐ | Cloud EMR + LIMS + PM. Claims more than 300 providers. Lab portal with Nova Genomics (2025) **[S]** |
| **ARTis** (artisivf.com, India; not Artisan) | ● timeline EMR | ● dynamic calendar: meds, E2/P4, ET thickness, follicles | ● | ● | ● ARTis Cryo, renewal/discard reminders | ◐ barcode/RFID | ◐ | ◐ | — | ● | ◐ | Colour-coded alerts for dues, viral markers, renewals. A useful UX pattern **[S]** |
| **BabySentry** (BabySentry Ltd) | ● | ● | ● | ● with imagery | ◐ | — | ◐ | ◐ | ◐ | ◐ | ◐ | "Paperless" workstations; analyser interface (Immulite 1000 hormones); first to integrate images **[S]** |
| **RI Witness** (CooperSurgical) | — | — | — | — | ◐ | ● RFID 13.56 MHz tags on all plasticware; reader worktops; patient RFID card; mismatch alarm | — | — | — | — | ● RI Witness IQ analytics | No scanning step for the embryologist. Integrates with clinic DB "subject to compatibility" **[S vendor]** |
| **IMT Matcher** (IMT/Planer) | — | — | — | — | ● lot tracking, cryo mgmt | ● camera-read barcodes; biometric ID; photo history of each step; UniTrack embryo-biopsy matching for PGT | — | — | — | — | ● audit reports | Scheduling + labelling included **[S vendor]** |
| **Vitrolife eWitness** | — | — | — | — | ◐ | ● scan, register, validate each action | — | — | — | — | — | **[S vendor]** |
| **TMRW** (+ Cryogatt patents 2025) | — | — | — | — | ● barcode + RFID CryoBeacon per device; automated LN2 refill; 24/7 monitoring; digital audit trail; retrofit of non-TMRW tanks | ● chain of custody | — | — | — | — | — | FDA/CE. Used at CCRM **[S]** |
| **EmbryoScope / EmbryoViewer** (Vitrolife) | — | — | — | ● morphokinetic annotations; iDAScore / KIDScore decision support | — | — | — | — | — | — | — | Central server for multi-incubator data; custom exports. **No public EMR API found**, so integration means file/DB export **[S]** |
| **QA tools**: CHLOE KPI (Fairtility), ART Compass, IVFQC "Reflections" | — | — | — | — | — | — | — | — | — | — | ● live KPI vs benchmark, multi-lab; per-technician competency; instrument QC data (incubators etc.) | **[S]** |
| **Patient layer**: Salve | — | — | — | — | — | — | — | ● white-label app over any EMR, staff dashboard | — | — | — | Claims up to 80% less admin/phone work; acquisition chain unverified **[S]** |
| **Storage billing**: Embryo Options (CooperSurgical), Wawa Fertility | — | — | — | — | ● | — | — | ● autopay enrolment | — | ● recurring storage billing, dunning | ● consent-status dashboard | Disposition completion stops auto-billing; statutory re-consent notices **[S]** |
| **Regional**: MedART (Meddilink), LifeLinkr | ● | ● | ● | ● | ◐ | ◐ | ◐ | ◐ | — | ● | ◐ | Market in UAE/Qatar/Oman; Arabic or multilingual prescriptions claimed **[S marketing]** |

**Requested but not found or unverified:** *Kyra*, *IVF Manager / ClinicSoft*, *IVF Online* (as software), *CryoGatekeeper*. No credible product pages turned up. The table substitutes the closest equivalents found: Cryohexagon and AUDITY (RFID+barcode witnessing through biopsy and cryo), Reprotech Smartsleeve (data-matrix cryo location verification, listed as "coming 2026").

### 1.2 Module checklist distilled from the field (what "complete" means)

| Domain | Must capture / do | Seen in |
|---|---|---|
| Couple & cycle | Couple as the unit (female + male partner); cycle types: fresh IVF/ICSI, FET, IUI, oocyte/sperm freezing, PGT, natural/modified natural; cycle status machine (planned → stim → triggered → OPU → culture → ET/freeze-all → luteal → β-hCG → CPR → outcome) | all EMRs |
| Stimulation | Protocol templates (long agonist, antagonist, PPOS, mild, natural); daily dose calendar; monitoring flowsheet (follicle sizes per ovary, endometrium, E2/LH/P4); trigger decision (hCG vs GnRHa vs dual) with exact time, since OPU is about 34–38 h later (36 h most common) | ARTis calendar, eIVF flowsheet, MedITEX |
| OPU | Theatre slot, anaesthesia, follicles aspirated, COCs retrieved, complications (Maribor %CoOPU) | all |
| Andrology | WHO semen parameters, CASA interface, prep method, post-prep motility (Vienna PI ≥95% benchmark), surgical sperm retrieval (TESE/micro-TESE), sperm freezing | MedITEX, BabySentry |
| ICSI / IVF lab sheet | **Per oocyte**: maturity (GV/MI/MII/degenerate), dysmorphisms, insemination time, operator; **Day 1** PN (2PN/1PN/3PN/"PN not observed"), PB; **Day 2–3** cell number, fragmentation, symmetry, multinucleation; **Day 4** compaction; **Day 5–7** Gardner/Istanbul blast grade; fate per embryo (ET / freeze / biopsy / discard / culture) | MedITEX, Artisan, IDEAS |
| PGT | Biopsy day, sample ID ↔ embryo ID matching, lab sent to, result per embryo (euploid/aneuploid/mosaic/no result) | MedITEX PID, Matcher UniTrack |
| Transfer | Embryos transferred (number, grade, day), catheter, difficulty, operator, witness; fresh or FET | all |
| Cryo | Device (straw/vial/cryotop) → canister → goblet → tank map; freeze/warm events; survival per embryo; storage-consent expiry; storage billing | MedITEX, TMRW, ARTis Cryo, Embryo Options |
| Luteal & outcome | Luteal support plan; β-hCG; clinical pregnancy (sac/FH); miscarriage/ectopic; delivery; live births, sex, weight, GA, malformations | registry-driven EMRs |
| Donor/surrogacy | Donor bank, matching, compliance (**disabled in Egypt**, see §3) | eIVF, IDEAS, MedITEX |
| Consents | Treatment, ICSI, freezing, storage duration, disposition on death/divorce/withdrawal, PGT; e-signature; renewal tracking | MedITEX, eIVF, HFEA forms |
| Witnessing | Every step in HFEA GN18 (a)–(m); electronic (barcode/RFID) with forcing functions; mismatch log with resolution | RI Witness, Matcher, eWitness |
| Patient portal | Protocol/med calendar, instructions, results, consents, payments, messaging | eIVF Patient, Salve, MedITEX Hope/Connect |
| Reporting | Vienna and Maribor KPIs per operator/period, registry export, CLBR per OPU | MedITEX KPI, eIVF Fertility Vision, CHLOE KPI |

**Notable UX patterns worth copying [S/I]:**
- **Timeline/calendar** of the cycle with doses, scans and labs on one axis (ARTis, eIVF flowsheet).
- **Colour-coded alert chips** on the patient banner for viral markers, dues and storage renewal (ARTis).
- **Per-oocyte grid** (rows = oocytes, columns = Day 0…6) with the embryo's fate at the end of each row. This is the de-facto embryology screen.
- **Mismatch-blocking ("forcing function")** witness prompts that cannot be skipped (RI Witness, Matcher).
- **Role landing pages** for nurse, clinician, embryologist and management (MedITEX).
- **Patient app pushing the protocol** directly from the clinic record (MedITEX Hope, eIVF Patient).

---

## 2. Standards and KPIs

### 2.1 Embryo assessment schemes

| Scheme | Content | Design implication **[I]** |
|---|---|---|
| **Istanbul consensus 2011** (ALPHA/ESHRE) | Static check timings in hours post-insemination (hpi): fertilisation 17±1; syngamy 23±1; early cleavage 26±1 (ICSI) / 28±1 (IVF); Day 2 44±1; Day 3 68±1; Day 4 92±2; Day 5 116±2. Cleavage fragmentation <10% / 10–25% / >25%; unequal blastomeres = more than 25% diameter difference; multinucleation ≥3 nuclei is negative | Store **observation time (hpi) per assessment**, not just the "day" |
| **Istanbul update 2025** (Hum Reprod 40(6):989, DOI 10.1093/humrep/deaf021) | 20 recommendations. PN check **16–17 hpi**; static syngamy check no longer recommended. Say "PN not observed", not "0PN". 1PN may be used cautiously (with blast culture or PGT-A); 2.1PN may be considered; **3PN not for clinical use**. Exclude giant oocytes (>180 µm). Rescue-IVM MI oocytes that mature within 2–6 h may be injected. **ICM/TE graded A–D** (D = non-viable). Day 7 blastocysts may be used. Cleavage ranked top/intermediate/low. Each lab should build its own morphokinetic reference data | Grading scheme must be **versioned and configurable per clinic** (A–C vs A–D); keep "reason for grade" |
| **Gardner blastocyst** | Expansion 1–6 (1 early: cavity under half the embryo's volume; 2 half or more; 3 full; 4 expanded with thinning zona; 5 hatching; 6 hatched). ICM A/B/C (tightly packed / loose / very few cells). TE A/B/C (cohesive epithelium / few, loose / very few). ICM and TE graded only at expansion ≥3 | Composite code such as "4AA" plus separate fields for analytics |
| **Time-lapse** (EmbryoScope etc.) | t2…t8, tSB, tB, plus AI scores (iDAScore, KIDScore). Two RCTs showed no live-birth gain from algorithmic selection | Import as optional per-embryo fields; never required |

### 2.2 Vienna consensus: IVF laboratory indicators (ESHRE SIG Embryology + ALPHA, RBMO 2017;35:494–510) **[P]**

Reference population: female age under 40, own fresh oocytes, ejaculated sperm (fresh or frozen), no PGT, IVF and ICSI. Collect monthly or per batch of about 30 cases.

**Key performance indicators (Table 4)**

| KPI | Calculation | Competency | Benchmark |
|---|---|---|---|
| ICSI damage rate | damaged or degenerated / all oocytes injected | ≤10% | ≤5% |
| ICSI normal fertilisation | 2PN+2PB / MII injected | ≥65% | ≥80% |
| IVF normal fertilisation | 2PN+2PB / COC inseminated | ≥60% | ≥75% |
| Failed fertilisation (IVF) | cycles with no fertilisation / stimulated IVF cycles | — | <5% |
| Cleavage rate | cleaved on Day 2 / 2PN on Day 1 | ≥95% | ≥99% |
| Day 2 embryo development | 4-cell on Day 2 / normally fertilised | ≥50% | ≥80% |
| Day 3 embryo development | 8-cell on Day 3 / normally fertilised | ≥45% | ≥70% |
| Blastocyst development | blastocysts on Day 5 / normally fertilised | ≥40% | ≥60% |
| Successful biopsy | biopsies with DNA detected / biopsies performed | ≥90% | ≥95% |
| Blastocyst cryosurvival | intact / warmed | ≥90% | ≥99% |
| Implantation (cleavage) | sacs / embryos transferred | ≥25% | ≥35% |
| Implantation (blastocyst) | sacs / blastocysts transferred | ≥35% | ≥60% |

**Performance indicators (Table 3)**

| PI | Calculation | Competency | Benchmark |
|---|---|---|---|
| Sperm motility post-prep (IVF/IUI) | progressively motile / all counted | 90% | ≥95% |
| IVF polyspermy | >2PN / COC inseminated | — | <6% |
| 1PN rate (IVF) | 1PN / COC inseminated | — | <5% |
| 1PN rate (ICSI) | 1PN / MII injected | — | <3% |
| **Good** blastocyst development | good-quality blasts on Day 5 / 2PN on Day 1 | ≥30% | ≥40% |

*Footnote: a secondary summary of the Istanbul 2025 update cited these 1PN values swapped. The primary Vienna table above is authoritative. Do not confuse the PI "good blastocyst rate" (≥30/≥40) with the KPI "blastocyst rate" (≥40/≥60).*

**Reference indicators (Table 2):** oocytes recovered / follicles on trigger day, 80–95%. MII at ICSI / COC retrieved, 75–90%.

### 2.3 Maribor consensus: clinical indicators (ESHRE, Hum Reprod Open 2021, hoab022) **[P]**

| PI | Calculation | Competence | Benchmark |
|---|---|---|---|
| %CCR, cancellation before OPU | cancelled / started cycles | 6 (ref) · poor responders 40 · normal 20 · high 3 | 3.5 · 20 · 7 · 1.5 |
| %mosOHSS, moderate/severe OHSS (antagonist) | cycles with mod/sev OHSS / started | 1.5 (ref) · normal 3 · high 3 | 0.5 · 0.5 · 1.5 |
| %mosOHSS (agonist) | same | 2.5 · 6 · 11 | 1 · 2 · 5.5 |
| %MII at ICSI | MII / COC | 74 | 75–90 |
| %CoOPU, complications after OPU | complications needing intervention/admission (excluding OHSS) / OPUs | 0.5 | 0.1 |
| %CPR | clinical pregnancies / ET cycles | not defined, set locally (published mean 32.2%) | — |
| %MPR, multiple pregnancy | multiple / pregnancies | 13 | 7.5 |

Calculate every 6 months or per 100 cycles; CPR and MPR every 3 months or per 50 cycles. **Design [I]:** responder class (poor/normal/high) must be a stored cycle attribute, and the protocol family (agonist/antagonist) a stored field, so these stratified KPIs can be computed.

### 2.4 Outcome definitions and registry reporting

| Item | Definition / source | Design implication **[I]** |
|---|---|---|
| ICMART/WHO glossary | 2009: 87 terms. **2017 International Glossary on Infertility and Fertility Care**: 247 terms, from fertility to birth (Hum Reprod, DOI 10.1093/humrep/dex234). Delivery rate is per initiated cycle, per aspiration or per ET | Use glossary terms as the canonical enum labels (EN) with Arabic equivalents |
| **CLBR per OPU** | SART: chance of live birth from all transfers (fresh + frozen) of embryos from one retrieval, within 1 year of it; "primary" = first transfer only; denominators by **cycle start / intended retrieval** | Every embryo and FET must carry `source_opu_id`, so outcomes roll up to the originating OPU across later FETs |
| SART CORS / CDC NASS fields | Patient demographics, diagnosis, cycle type, stimulation, oocytes, embryos, transfer, outcome to birth (plurality, birthweight, GA). Validation found >95% agreement with vital records for live birth and plurality. **The field-level data dictionary was not retrieved** | Model a superset; export per registry |
| ESHRE EIM | European monitoring from national registries; per-started-cycle rates plus rising FET share. **EIM methodology not retrieved** | — |
| Egyptian registry | Egyptian IVF registry on ICMART forms: 18 centres in 2003, 15 in 2004, 16,862 cycles, **ICSI 91.9%**; 2005: 10,353 cycles. Data is old | ICSI is the default path; reuse the ICMART form structure |
| MedITEX Registry | Exports to DIR, FIVNAT, HFEA, ANZARD, RetePMA | Registry export is table stakes |

### 2.5 Traceability and witnessing: HFEA Code of Practice, 9th ed. v4 (Oct 2024), Guidance Note 18 **[P]**

**Witnessed steps (18.4):**

| # | Step | Check |
|---|---|---|
| a | Egg collection | Patient states own identity vs records/lab sheet; dish labels vs records (manual check not needed if barcode/RFID) |
| b | Sperm collection | Provider identity vs records, lab sheet, receptacle |
| c | Sperm preparation | Tube vs records/receptacle (manual check not needed if electronic) |
| d | Mixing eggs and sperm / ICSI | Verify dishes and tubes; confirm they should be combined |
| e | Transfer between dishes/tubes | Source vs destination vs records |
| f | Embryo transfer | Patient identity vs records and lab sheet; ET dish vs records |
| g | IUI with lab-prepared sperm | Patient + sperm-provider identity |
| h | Into cryo | Container vs records vs source dish; **position in dewar** |
| i | Out of cryo | Container vs records; thaw dish labelled/tagged |
| j | Disposal | Container vs records |
| k | Transport | Container vs records; container info correct |
| l | Mitochondrial donation | (N/A in Egypt) |
| m | Donor allocation | (N/A in Egypt) |

- **Identifiers (18.5, 18.21–22):** full name plus 2 of {DOB, hospital no., national no., patient code}, on every dish, tube and straw. Keep manual labels even when using barcode/RFID (18.41).
- **Record per check (18.8):** what was checked, date and time, signature of the operator, signature of the witness. Keep a separate register of name, job title and signature for everyone who performs or witnesses (18.9).
- **Patient states own name and DOB** (18.19). Do not read details out for the patient to confirm.
- **Irreversible steps** (thaw, mixing) must be witnessed **before** they are done (18.7).
- **Electronic witnessing:** risk assessment (18.33). Every mismatch is logged and must be resolved with a written explanation before continuing (18.36). With forcing functions, manual checks of transfer steps may be dropped, **except** mixing, injection, and placement into or removal from cryo (18.37). Unique user IDs (18.38). A manual fallback is required if the system fails (18.40).
- **Biopsy (18.6):** embryo and biopsy sample must be co-labelled.
- **Retention:** traceability data for **at least 30 years** (HFEA T103; EU Directive 2004/23/EC Art. 8(4); 2006/86/EC Art. 9(2)).

### 2.6 Storage consent and renewal (UK model since 1 Jul 2022) **[P]**

| Rule | Value |
|---|---|
| Max storage (own treatment) | 55 years, **re-consent every 10 years** (or a shorter consented period) |
| Donors | Up to 55 years without 10-year renewal |
| After death (with consent) | Up to 10 years from date of death |
| Withdrawal by one gamete provider | 12-month "cooling-off" before mandatory disposal; notify the other party |
| Failure of one provider to renew | Further 6-month grace from end of renewal period |
| Clinic duty | **Bring-forward system** to prompt renewal (CoP 17.12); record contact attempts; keep renewal forms |

UAE comparison: embryos and gametes stored for 5 years, extendable for similar periods on the couple's written request. Embryos no longer needed are left to perish naturally unless the parties request otherwise (Fed. Law 7/2019 Arts 10–11) **[S]**.

---

## 3. Regional context: Egypt and MENA

### 3.1 Rules

| Topic | Egypt | Saudi Arabia | UAE |
|---|---|---|---|
| Legal basis | **No dedicated ART statute.** Medical ethics regulations (MoH Decree 238/2003) plus Al-Azhar / Dar al-Ifta fatwas. A MoH **draft ART law** was sent to the Ministry of Justice (reported **8 Jul 2025**); status since unknown **[S]** | Law of Fertilization, Utero-Fetal and Infertility Treatment Units, Royal Decree **M/76 (21/11/1424H)** + implementing regulations; annual case reports to MoH **[P/S]** | Fed. Law **7/2019** + exec. regs (in force 1 Jan 2021) + Decree-Law 17/2023 (covers free zones) **[S]** |
| Who may be treated | Married husband and wife, own gametes only | Existing marriage; written consent of both spouses **[S]** | Married couple |
| Donor gametes / embryos | **Prohibited** (Decree 238/2003 Art. 45 per a 2019 review) **[S]** | Prohibited | Prohibited |
| Gamete/embryo banks, trade | **Prohibited** (Arts. 45(2), 46, 51 per the same review). *Egypt Telegraph 2025 cites Arts. 44–45; the primary text was not retrieved* | — | — |
| Surrogacy | Prohibited (fatwa 2001; the draft law bans it in all cases) | Prohibited | Prohibited |
| Embryo freezing | Permitted for married couples. Embryos must be stored securely to prevent mix-up and never go to another woman **[S Dar al-Ifta]** | Permitted (details not retrieved) | Permitted, 5 years renewable |
| After divorce | Transfer **prohibited** | Fertilisation after divorce prohibited **[S]** | — |
| After husband's death | Transfer permitted **only within the widow's iddah** if the embryo was created during the marriage with consent (Dar al-Ifta fatwa 20818); the draft law bans fertilisation after death | Prohibited **[S]** | — |
| Egg freezing | Permitted (Dar al-Ifta 2019) on condition of fertilisation by the husband during the marriage | — | Permitted |
| National database | Draft law: clinics electronically linked to a **national database** tracking fertilisation, transfer and freezing, to prevent mix-ups | Annual reports | Licensing by MoHAP and emirate authorities |
| Licensing | Draft: OB/GYN with a special ART licence + separately licensed centres; a permanent high committee | MoH licence | MoHAP / DoH / DHA |
| Medical-records retention | **Not found.** Medical Liability Law **13/2025** exists; its retention article was not retrieved | Not retrieved | Abu Dhabi DoH: 5 years from last treatment (general records) |

### 3.2 Design constraints derived from the rules **[I]**

1. **Couple record = husband + wife + marriage evidence** (marriage certificate number/date, upload). Re-verify marriage at each embryo transfer and thaw, and block if the marriage status is divorced.
2. **Gamete-source invariant:** an oocyte must belong to the wife and sperm to the husband of the same couple. The donor and surrogacy modules are **disabled by policy (feature flag per jurisdiction)**, not merely hidden, and any override attempt is audited.
3. **Disposition state machine** per embryo and gamete: `stored → (transfer | discard | research-consented | export)`. Marriage events (divorce or death recorded) automatically freeze stored material against transfer. After a death, a configurable **iddah window** (default 4 months 10 days for a widow, as configured per clinic's religious-legal advice) permits transfer; after it expires, the material is locked and a disposal decision is required.
4. **Retention default = 30 years** for lab/traceability data (HFEA/EU conservative standard) until Egyptian rules are confirmed. Hard-delete is disabled for ART records.
5. **National-database readiness:** keep a registry-export abstraction (ICMART-shaped) so a future MoH feed can be added without a schema change.
6. **Sex selection / PGT for social reasons:** a regional medical-tourism package advertises "IVF with Gender Selection" in Cairo, and this is legally contested. Keep the PGT indication as an explicit coded field (medical / aneuploidy / monogenic / other) for audit.

### 3.3 What MENA centres use and Arabic UI expectations

- **Vendors with regional footprint [S]:** MedITEX (UAE testimonial), MedART (Arabic support claimed, more than 250 clinics in 25 countries), LifeLinkr (UAE/Qatar/Oman marketing), and international EMRs in chain groups (e.g. IVI-RMA acquisitions in UAE/KSA). Many Egyptian private centres run paper lab sheets plus generic HIS or Excel. This is an **observation, not sourced**; validate it with client interviews.
- **Arabic UI expectations [I, from Moon ERP context, not web sources]:** RTL-first layout with LTR islands (grades such as "4AA", hpi, drug codes); bilingual Arabic and English consent forms with e-signature; Arabic four-part names plus English transliteration for labels; 14-digit Egyptian national ID as a label identifier (satisfies the "full name + 2 identifiers" rule together with the file number); Arabic labels for cycle stages while lab grades stay in international notation; printable Arabic patient instructions (injection calendar); WhatsApp/SMS reminders.

---

## 4. Commercial and operations

| Topic | Market practice | Moon ERP design **[I]** |
|---|---|---|
| Package pricing | Cycle package (OPU + ICSI + ET) at a fixed price. Egypt aggregators cite **about 40k–80k EGP** per standard cycle excluding drugs; Cairo ICSI **about $2.8k–4.2k**, with PGT-A **$4.5k–7k**, FET **$1.1k–1.8k** **[S, aggregator quality]** | Package = bill of services with an **included/excluded matrix** and price versions |
| Multi-cycle / refund ("shared-risk") | Prepay a higher fee; refund 50–80% if no pregnancy/live birth within a time window; strict eligibility. **Medications always excluded**; often also anaesthesia, ICSI, AH, cryo. ASRM: criteria must be stated transparently up front **[S]** | Package contracts with eligibility rules, a refund clause and revenue deferral (accounting) |
| Per-stage billing | Stage charges: consultation → monitoring (flat per cycle) → OPU → lab (ICSI/AH/PGT add-ons) → ET → freezing → FET | Bill on **cycle milestones** (status transitions), not ad-hoc invoices |
| Cryo storage fees | Annual (eggs/embryos) or 6-monthly (sperm) recurring fees; autopay; dunning; non-payment may lead to an "abandoned" designation and discard per contract; consent-status dashboard; disposition stops billing (Embryo Options, Wawa, ARTis Cryo) **[S]** | **Storage subscription** per frozen batch, linked to consent expiry; renewal reminders at T-90/60/30 days; billing stops automatically when disposition is completed |
| Drugs and consumables | Egypt: gonadotropin and antagonist price shocks (antagonist about $20/ampoule at government pharmacy vs $36 on the black market) pushed many clinics to **freeze-all** **[S, MEFJ 2024]** | Use Moon ERP Inventory for gonadotropins: lot/expiry, **2–8 °C cold chain**, per-cycle dispense against the stim calendar, patient-supplied vs clinic-supplied drugs, and media/consumable lot numbers recorded on the lab sheet (traceability). Lab media lot numbers per dish **[I]** |
| Scheduling | Theatre (OPU/ET) slots driven by trigger time + 34–38 h; embryologist capacity; incubator capacity; Day 3/5 transfer planning; andrology slots on OPU morning | Resource calendar (rooms, embryologists, incubators) fed by trigger time; an OPU list auto-generated from triggered cycles **[I]** |

---

## 5. Gaps and confidence

| Gap | Impact | Mitigation |
|---|---|---|
| Egyptian primary text (Decree 238/2003 articles; Law 13/2025 records retention; draft ART law text and status) | Legal rules rest on secondary sources | Owner/legal review; make rules configurable flags |
| SART CORS / EIM field dictionaries | Exact export schema unknown | Build a superset model; add mappers later |
| Vendor feature depth (IDEAS lab, BabySentry witnessing, Artisan lab) | Some matrix cells are ◐ or — | Request demos if competitive positioning matters |
| Egypt pricing (EGP) and storage fees | Aggregator data only | Collect price lists from pilot clients |
| Kyra, IVF Manager/ClinicSoft, IVF Online, CryoGatekeeper | Not verifiable | Treated as not found |

---

## 6. Top 10 capabilities for a best-in-class IVF module (Moon ERP)

1. **Couple-centred cycle engine**: husband + wife + marriage evidence; typed cycles (ICSI, IVF, FET, IUI, freezing, PGT) with an explicit status machine and milestone-driven billing.
2. **Stimulation planner and monitoring flowsheet**: protocol templates; daily dose calendar; follicle/endometrium/hormone grid; trigger time that auto-schedules OPU 34–38 h later; responder class captured.
3. **Per-oocyte ICSI/embryology lab sheet**: Day 0–7 grid with hpi-timed observations, versioned grading schemes (Istanbul 2011/2025, Gardner), per-embryo fate, photos, time-lapse import.
4. **Electronic witnessing and traceability**: HFEA GN18 steps (a)–(k) as forcing-function checkpoints; full name + 2 IDs on every label; operator and witness e-signatures; mismatch log; 30-year retention; manual fallback.
5. **Cryo inventory and storage lifecycle**: tank/canister/goblet/device map; freeze/warm events with survival; consent expiry with a bring-forward renewal workflow; recurring storage billing that stops on disposition.
6. **Jurisdiction rule engine (Egypt default)**: own-gametes-only invariant; donor/surrogacy disabled; transfer lock on divorce; iddah window after death; all overrides audited.
7. **Andrology module**: WHO semen analysis, CASA/LIS interface (reuse Moon LIS), preparation, surgical sperm retrieval, sperm freezing.
8. **Outcome follow-up to live birth**: β-hCG → CPR → delivery, linked by `source_opu_id`, so CLBR per OPU and registry (ICMART-shaped) exports compute automatically.
9. **KPI cockpit**: Vienna (12 KPIs + 5 PIs + 2 RIs) and Maribor (6 PIs) against competency and benchmark lines; per embryologist, clinician and period; minimum-n warnings.
10. **Integrated commerce and ops**: package contracts with an inclusion matrix; gonadotropin and media stock with lot/expiry/cold chain; theatre/embryologist/incubator scheduling; bilingual RTL patient portal/app (protocol calendar, consents, payments, reminders).

---

## Sources

**Standards and regulators (primary)**
- Vienna consensus, ART lab KPIs (ESHRE/ALPHA, RBMO 2017): https://www.eshre.eu/-/media/sitecore-files/SIGs/Safety-and-quality/The-Vienna-consenus_Lab-KPI.pdf · https://www.eshre.eu/Guidelines-and-Legal/Guidelines/ART-Lab-Performance-Indicators
- Maribor consensus, clinical PIs (Hum Reprod Open 2021): https://pmc.ncbi.nlm.nih.gov/articles/PMC8254491/ · https://eshre.eu/Guidelines-and-Legal/Guidelines/Performance-indicators-for-the-ART-Clinic
- Istanbul consensus update 2025: https://pmc.ncbi.nlm.nih.gov/articles/PMC12127515/ · https://academic.oup.com/humrep/article/40/6/989/8118863 · draft: https://www.eshre.eu/-/media/sitecore-files/Guidelines/Istanbul/The-Istanbul-consensus-update-2024---Draft-for-Review.pdf
- Gardner grading (ASRM Academy): https://www.asrm.org/asrm-academy/asrm-academy-on-the-go/embryo-data-grading--evaluation/grading-scales/ · https://pmc.ncbi.nlm.nih.gov/articles/PMC7943864
- HFEA Code of Practice 9th ed. v4 (Oct 2024), GN17/18/19, T103: https://portal.hfea.gov.uk/media/yrkn55xa/2024-10-01-hfea-code-of-practice-v9-4.pdf · https://portal.hfea.gov.uk/knowledge-base/read-the-code-of-practice/
- HFEA 2022 storage law: https://www.hfea.gov.uk/about-us/news-and-press-releases/2022-news-and-press-releases/new-law-comes-into-force-giving-greater-flexibility-for-fertility-patients/
- EU Directive 2004/23/EC Art. 8 (30-year traceability): https://www.legislation.gov.uk/eudr/2004/23/article/8 · 2006/86/EC Art. 9: https://www.legislation.gov.uk/eudr/2006/86/article/9
- WHO/ICMART glossary: https://www.who.int/teams/sexual-and-reproductive-health-and-research-(srh)/areas-of-work/fertility-care/ART-revised-glossary · 2017 update note: https://www.deutsches-ivf-register.de/perch/resources/downloads/jre32015eshre-2015icmartdemouzonj-1.pdf
- SART clinic report / CLBR: https://www.sart.org/ivf-success/understanding-the-sart-clinic-report/ · CORS validation: https://pmc.ncbi.nlm.nih.gov/articles/PMC5010979

**Regional**
- Review of ART laws in Muslim countries (MEFJ 2019): https://mefj.springeropen.com/articles/10.1186/s43043-019-0011-0
- Dar al-Ifta: embryo cryopreservation: https://www.dar-alifta.org/en/fatwa/details/14755/embryo-cryopreservation · transfer after husband's death: https://www.dar-alifta.org/en/fatwa/details/20818/transferring-fertilized-embryos-after-the-husbands-death · keeping frozen embryos (AR): https://www.dar-alifta.org/ar/fatwa/details/24255 · egg freezing 2019: https://petrieflom.law.harvard.edu/2019/09/23/egg-freezing-permissible-in-islam-according-to-egypts-dar-al-ifta/
- Egypt draft ART law (Egypt Telegraph, 8 Jul 2025): https://www.egypttelegraph.com/article/158119/
- Egypt Medical Liability Law 13/2025 (Andersen): https://eg.andersen.com/?p=27906
- Egyptian IVF registry 2003–05: https://doaj.org/article/df5b076a4c004ac28845c937a1fd0c73 · https://imse.ibp.georgetown.domains/items/show/33945
- Egypt drug costs and freeze-all (MEFJ 2024): https://mefj.springeropen.com/articles/10.1186/s43043-024-00208-3
- Saudi law M/76: https://www.moh.gov.sa/en/Ministry/Rules/Documents/Law-of-Fertilization-Utero-Fetal-and-Infertility-Treatment-Units.pdf · amendment: https://www.moh.gov.sa/en/Ministry/Rules/Documents/Amendment-of-Regulations-of-Fertilization-and-Utero-Fetal-and-Infertility-Treatment-Units-Law.pdf
- UAE Fed. Law 7/2019: https://mohap.gov.ae/app_content/legislations/php-law-en-96/files/basic-html/page5.html · https://www.mondaq.com/family-law/1394724/uaes-new-ivf-regulations-a-comprehensive-overview
- Abu Dhabi records retention: https://www.doh.gov.ae/-/media/62E2EFCEA06D4073812ED9913F4E4187.ashx

**Vendors and products (mostly vendor or secondary)**
- MedITEX: https://www.meditex.cloud/ · https://www.ivf.software/embryologist · https://www.ivf.software/nurse · https://www.ivf.software/management · https://softwarefinder.com/emr-software/meditex
- IDEAS: https://www.ivf.net/ivf/ideas-fertility-clinic-software-o3557.html · https://pulserevops.com/knowledge/tk0103
- eIVF: https://www.businesswire.com/news/home/20241015218274/en/eIVF-Expands-Fertility-Vision-to-Revolutionize-Embryology-Management · https://apps.apple.com/app/id892852665 · https://softwarefinder.com/emr-software/eivf · https://businesswire.com/news/home/20240319490239/en/
- Artisan / ARTis: https://txfertility.com/?p=21817 · https://www.fertilitybridge.com/news-articles/fertility-operations-software-patient-concierge · https://artisivf.com/ · https://artisivf.com/blog/2024/08/13/cryopreservation-renewals-boost-your-centres-financials/
- BabySentry: https://www.myshortlister.com/babysentry-ltd/vendor-reviews · https://blogs.pathology.jhu.edu/pathology/tag/in-vitro-fertilization
- RI Witness: https://www.coopersurgical.com/product/ri-witness-system/ · https://www.dukehealth.org/blog/duke-fertility-center-RI-witness · https://kindbody.com/kindbodys-chief-science-officer-on-state-of-the-art-identification-technology
- IMT Matcher: https://planer.com/products/traceability/imt-matcher · https://www.ivf.net/ivf/imt-matcher-electronic-witnessing-system-for-ivf-centres-and-donor-banks-o12953.html · https://reprotech.com/article/what-is-electronic-witnessing-in-ivf/
- Vitrolife eWitness / EmbryoScope: https://www.vitrolife.com/products/electronic-witnessing/ · https://www.vitrolife.com/link/d8d41cc19ea74312812af4ef75fd6418.aspx · https://blog.vitrolife.com/togetheralltheway/unleashing-clinic-efficiency-time-lapse-and-its-evaluation-software-tools-integration
- TMRW: https://www.tmrw.org/what-we-do · https://femtechinsider.com/tmrw-acquires-cryogatts-patents-to-enable-digital-upgrades-for-fertility-specimen-storage-systems/ · https://www.ccrmivf.com/egg-freezing/tmrw-cryostorage/
- QA tools: https://fairtility.com/chloe-kpi/ · https://ivf.net/ivf/ivf-quality-control-in-the-cloud-o11326.html
- Salve: https://app.dealroom.co/companies/salve · https://mindmaps.femtech.health/firms/8163
- Storage billing: https://www.coopersurgical.com/?p=11921 · https://www.wawafertility.com/product/cryo · https://nyulangone.org/locations/fertility-center/fertility-center-financial-information-patient-forms/embryo-egg-sperm-storage-fees
- Regional vendors: https://www.goodfirms.co/software/medart · https://www.lifelinkr.com/uae/

**Commercial**
- Egypt pricing (aggregators): https://www.placidway.com/answer-detail/569341/How-Much-Does-IVF-Cost-In-Egypt · https://www.placidway.com/search-medical-pricings/IVF-with-ICSI+Fertility-Treatment/Cairo+Egypt/1 · https://whatclinic.com/fertility/egypt/embryo-freezing · gender-selection package (Cairo): https://www.placidway.com/package/4803/IVF-with-Gender-Selection-Using-ICSI-Package-in-Cairo-Egypt
- Shared-risk programmes: https://www.centerforhumanreprod.com/shared-risk-program · https://www.nccrm.com/ivf-shared-risk-program/ · https://tfp-fertility.com/en-gb/tfp-nurture-fertility/fertility-treatment-costs/finance-and-refund-packages · ASRM ethics opinion: https://prod.asrm.org/practice-guidance/ethics-opinions/financial-risk-sharing-or-refund-programs-in-assisted-reproduction-an-ethics-committee-opinion-2016/