An IVF trial is a chain of events inside one treatment cycle: stimulation, trigger, egg retrieval, fertilisation, transfer and a pregnancy test, then months of follow-up to a birth. Capture holds each step as its own form on one participant record, with phone diaries, consent and an audit trail alongside. Build it free in the sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Assessment | Screen | Stim D1 | Stim D6 | Trigger | Retrieval | Transfer | hCG test | US 7 wk | Birth |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian response (scan, hormones) | |||||||||
| Stimulation dosing log | D | D | |||||||
| Oocyte and embryo record | |||||||||
| Pregnancy test and ultrasound | |||||||||
| Birth and neonatal outcome | |||||||||
| Adverse events (incl. OHSS) |
x = done at this step, D = daily dose log on phone
What an IVF trial needs from its EDC
The study data
Fertility trials cover a broad set of designs: adjunct drugs given during ovarian stimulation, comparisons of stimulation protocols or dosing strategies, luteal-phase support, embryo culture and transfer strategies (fresh against frozen), add-on procedures, and lifestyle or supplement interventions before treatment. They share one structural feature. The unit of treatment is the cycle, and one woman can contribute more than one. The study record therefore needs a participant level (demographics, infertility history, partner factors) and a cycle level (every step of that cycle), and your protocol must say whether a second cycle is a new participant episode or a continuation.
On the outcome side, an international consensus study that built a core outcome set for infertility research (a Delphi process with 372 participants followed by a 30-person workshop) placed viable intrauterine pregnancy confirmed by ultrasound, pregnancy loss, live birth, gestational age at delivery, birthweight, neonatal mortality and major congenital anomaly in the set, and advised reporting time to pregnancy leading to live birth where it applies. Registered IVF trials then choose their own primary: ongoing pregnancy leading to live birth, live birth, or in some protocols cumulative live birth across fresh and frozen transfers, with ovarian hyperstimulation syndrome and multiple pregnancy named as specified adverse events. These choices are protocol decisions. The EDC job is to store every date and count needed to derive them.
This page is the IVF-specific companion to EDC for fertility, endometriosis and PCOS trials, which covers cycle-anchored visits and daily pain diaries across reproductive health. Here the focus is assisted reproduction: the stimulation, retrieval and embryo chain, and the pregnancy follow-up that depends on it.
Embryo records are naturally a table: one row per embryo with its day of development, grade, whether it was transferred, frozen or discarded, and the date. Capture’s table sections hold repeating rows on an eCRF form, and each row carries its own audit trail, so a grade changed after review shows the old value, the new value, who changed it and why. Use a calculated field for the age of the woman at retrieval from her date of birth, and an edit check to raise a query if the number of embryos transferred exceeds the cap in the protocol.
Retrieval
Date of oocyte retrieval
RETDTCOocytes retrieved
OOCRETMature (MII) oocytes
OOCMIIFertilised (2PN)
FERT2PNAge at retrieval
AGERETRead-only, from date of birth
34 years CalculatedEmbryos transferred
EMBTRNProtocol allows a maximum of 2 embryos. Query raised.
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility | Age, infertility duration and cause, prior cycles, ovarian reserve results, BMI | Eligibility form, demographics and a calculated BMI |
| Allocation | Treatment arm, stratified by age band or prior-cycle count | Randomization in the same platform; blinded roles never see the arm |
| Stimulation | Drug, daily dose, start and stop dates, missed doses | Repeating dosing form and a short phone log; see medication adherence capture |
| Ovarian response | Follicle counts, estradiol and other hormone results, cycle cancellation reason | Visit form plus lab results with reference ranges |
| Retrieval and embryos | Oocytes by maturity, fertilisation, embryo table, transfer decision | Table section on an eCRF form (one row per embryo) |
| Pregnancy | hCG result, ultrasound findings, pregnancy loss, ongoing pregnancy date | Dated outcome forms; derived outcomes calculated by the statistician from the export |
| Birth and neonate | Delivery date, mode, gestational age, birthweight, congenital anomaly | Outcome form completed by the site from the delivery record |
| Safety | OHSS grade, multiple pregnancy, complications, SAEs | Adverse event form and SAE report form |
Capture records the data your protocol defines. Cycle definitions, outcome denominators and clinical judgements belong to the protocol and the statistical plan.
Upload the protocol, let the AI draft the visits and forms for review, then run a practice cycle through stimulation, retrieval, transfer and a positive test. Free sandbox.
Long follow-up
The longest-running data in an IVF trial is the pregnancy that follows. A positive hCG test, an ultrasound that shows a viable intrauterine pregnancy, an ongoing pregnancy at a protocol-defined point and a delivery are separate dated events, and each can fail. Build them as separate forms so a pregnancy loss is recorded as a dated event with its type, not as a blank where a birth should be. Loss to follow-up is its own, honest status: a participant who stopped answering is not the same as one who did not conceive.
Because delivery can be nine months or more after the transfer, plan contact. The participant can answer short questionnaires from a link on her phone, with no app install, and the compliance view shows by site who is overdue; see ePRO compliance and reminders and BYOD ePRO without an app download. Birth details usually come from the site or the delivering hospital, so keep a site-completed outcome form with the source noted, and decide how you will obtain records when the participant delivers elsewhere. Neonatal follow-up beyond the first weeks is a protocol and ethics decision.
Visit windows, expected dates and out-of-window flags are set per form, so a late pregnancy-test form is visible to the coordinator rather than discovered at database lock. The same applies to missing data, which the data management plan template is a good place to define in advance.
Safety reporting
Safety in fertility trials is wider than a single adverse event list. Ovarian hyperstimulation syndrome is a recognised complication of stimulation and is named as a specified adverse event in registered protocols; multiple pregnancy, ectopic pregnancy, pregnancy complications and congenital anomalies are others. Give each its own structured field or severity grade so the safety table does not rely on free text, and keep severity, seriousness and causality as separate answers; the AE causality assessment page and the AE seriousness decision tree explain the split.
An event in a pregnancy or in a newborn is attached to the participant’s record, but the person affected may be the child. Check with the sponsor and your ethics committee how neonatal events are classified, who reports them and under which clock. The SAE reporting deadline calculator helps with planning the timelines, and the SAE report form shows the structure of the report.
Build sequence
A realistic order of work for a clinic network, university or sponsor.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the schedule and forms. Nothing is saved until a person reviews it.
Decide which events anchor the visits, how a repeat cycle is recorded, and which dates are mandatory.
Counts as numbers, the embryo table as repeating rows, edit checks for caps and impossible sequences such as more fertilised than mature oocytes.
Separate dated outcome forms and structured OHSS and multiple-pregnancy fields, with the audit trail on every change.
Run practice participants through a cancelled cycle, a loss and a live birth, approve the forms and start the paid live phase when real participants enrol.
Consent, sites and exports
Consent in fertility research often covers more than one thing: participation in the trial, use of embryos or gametes, and sometimes data from a partner. Capture’s eConsent has on-screen signature after an email one-time code, investigator countersignature with password re-authentication, optional witness signature, and a signed PDF export; see eConsent for clinical trials and eConsent software for clinical trials. Which consents you need, and whether a partner is a participant, are ethics committee questions.
Clinic networks use QR-code enrolment, site-level numbering, a site coordinator portal, role-based access that keeps names with the site while researchers see coded IDs, and by-site exports; see multi-site clinical trial management. Exports come as CSV or Excel with an automatic data dictionary, and SDTM datasets as SAS XPT with Define-XML are available (SDTM export).
Before first participant
What counts as a started cycle, a cancelled cycle and a repeat cycle, written into the protocol and the form design.
Live birth, ongoing pregnancy or cumulative live birth, per cycle, per transfer or per woman.
How births at other hospitals are traced and how loss to follow-up is recorded.
OHSS grading, multiple pregnancy, anomalies and who reports neonatal events.
Trial, embryo or gamete use and partner data, as the ethics committee requires.
Wide CSV with data dictionary opened in the statistics package, with one row per cycle and embryo table separate.
Yes. A table section on an eCRF form holds repeating rows, so each embryo can have its own grade, fate and date, and each row carries its own audit trail.
Yes. Build separate dated forms for the pregnancy test, ultrasound, ongoing pregnancy, delivery and neonatal outcome, and use visit windows and the compliance view to see what is overdue.
Capture stores the dates and counts. The endpoint and its denominator are defined in your statistical plan and derived from the export; Capture does not decide them.
Yes. A range or custom value rule on the field raises an auto-query when the entry breaks the limit you set from the protocol.
It is a design decision. A common approach is a repeating cycle set of forms under one participant, or a new episode with its own identifier. Your protocol and statistician should choose before the build.
Capture provides 21 CFR Part 11-aligned controls: a field-level audit trail, electronic signatures and role-based access. Compliance is shared with the sponsor’s own validated use of the system. This is not legal advice.
Keep exploring
EDC for fertility, endometriosis and PCOS trials
Cycle-anchored visits and daily diaries across reproductive health.
Adverse event eCRF template
Event structure with severity and causality.
EDC with randomization
Stratified allocation inside the study.
Capture eConsent
On-screen signature and countersignature.
Capture eCRF builder
Forms, edit checks and repeating rows.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.