Therapeutic area · Reproductive healthUpdated September 28, 2026

EDC for fertility, endometriosis and PCOS trials

Reproductive health trials follow cycles, not calendars, and often continue to pregnancy outcomes months after treatment. Endometriosis trials depend on daily pain and bleeding diaries. Capture handles cycle-anchored visits, daily diaries and long follow-up in one study.

  • Visits anchored to key events
  • Daily pain and bleeding diaries
  • Pregnancy follow-up

Free sandbox · No credit card · 21 CFR Part 11 aligned

Daily pelvic pain diary

Tuesday · Day 17 of cycle

Bleeding today

NoneSpottingLightModerateHeavy

Worst pelvic pain in the last 24 hours

012345678910

Pain medication taken

NoYes
Bleeding status classifies each pain day

What matters in reproductive health trials

  • Fertility trials increasingly use live birth as the primary outcome, recommended by core outcome sets for infertility research, rather than pregnancy tests or clinical pregnancy alone.
  • That means follow-up continues through pregnancy to delivery, often nine months or more after treatment, with neonatal outcomes recorded too.
  • Endometriosis trials commonly use daily ratings of dysmenorrhoea and non-menstrual pelvic pain, classified by bleeding status, plus analgesic use.
  • PCOS trials measure ovulation, menstrual cyclicity, hyperandrogenism and metabolic outcomes, depending on the treatment goal.
  • Treatments that suppress hormones may need bone mineral density monitoring as a safety measure.

Study design

Schedules that follow the cycle

An IVF cycle has its own timeline: stimulation starts on a cycle day, monitoring visits follow as follicles grow, and retrieval, transfer and pregnancy tests happen at intervals that depend on those events. Visits in the study should be anchored to the right event, such as the start of stimulation or the day of embryo transfer, with windows around them, rather than fixed calendar weeks from randomisation.

Cycle-level data matters for interpretation: stimulation days and total gonadotropin dose, oocytes retrieved, fertilisation and embryo data, and the number and quality of embryos transferred. Safety data includes ovarian hyperstimulation syndrome, which needs its own grading. Structured forms for each step make the cycle reconstructable.

Couples and partners

Fertility trials often collect data about the partner, such as semen parameters, and outcomes involve a pregnancy and a baby. Consent needs to cover each person whose data is collected, and the study design should state how partner and neonatal data link to the participant's record.

Example IVF trial timeline
1234567891011121314151617181920212223242526272829303132333435363738394041424344

Weeks

Stimulation
Retrieval and transfer
Pregnancy test and ultrasound
Pregnancy follow-up
Live birth and neonatal outcome
Visits anchored to key cycle events

Daily diaries

Pain and bleeding recorded every day

Endometriosis endpoints depend on daily entries: pain severity, bleeding status and analgesic use. Participants complete a short diary each evening from a secure link on their phone. Completion windows stop back-filling, reminders prompt missed entries, and compliance is visible per participant.

  • Daily diary with a completion window.
  • Reminders by email or SMS.
  • Compliance per participant on the dashboard.
Patient diary software
ePRO compliance by site
Site 0194%
Site 0281%
Site 0358%

At-risk participants

03-0073 diary entries missedReminder delivered
03-011Week 4 questionnaire overdueEmail bounced

Build a cycle-anchored schedule and a pain diary

Try both in the free sandbox on your phone.

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Endpoints

Endpoints by condition

ConditionTypical endpointsData needed
Infertility (IVF, ovulation induction)Live birth, clinical and ongoing pregnancy, pregnancy lossCycle forms, ultrasound results, pregnancy and delivery follow-up
EndometriosisDysmenorrhoea and non-menstrual pelvic pain responders, dyspareunia, quality of lifeDaily pain and bleeding diary, analgesic use, questionnaires
PCOSOvulation, menstrual cyclicity, hirsutism score, metabolic measuresCycle records, hormone and metabolic labs, clinician ratings
Heavy menstrual bleedingMenstrual blood loss, bleeding daysBleeding diaries or product collection methods

Safety and follow-up

Pregnancy is an outcome and a safety event

In fertility trials pregnancy is the goal; in most other trials it is a safety event requiring follow-up. Either way, pregnancy outcome forms should record gestational age at delivery, mode of delivery, birthweight, neonatal status and congenital anomalies, with the same structure across sites. Long follow-up means participants move, change doctors and become hard to reach, so collect consented contact details and plan outcome ascertainment from the start.

For hormonal treatments in endometriosis and PCOS, safety monitoring may include bone density, lipids and liver function. Schedule them as visit assessments with the same forms at each site. See adverse event reporting software.

Study build

Reproductive health study build checklist

Anchor events

Stimulation start, transfer or cycle day defined for visit timing.

Outcome definitions

Live birth, clinical pregnancy and loss defined per protocol.

Partner and neonatal data

Consent and record linkage planned.

Daily diary

Pain, bleeding and analgesic fields matched to endpoints.

Safety monitoring

OHSS grading, bone density or labs as needed.

Long follow-up

Contact details and ascertainment plan for pregnancy outcomes.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

What is the preferred primary outcome in fertility trials?

Live birth is increasingly recommended, rather than pregnancy tests or clinical pregnancy alone.

How are endometriosis pain endpoints measured?

Usually with daily ratings of dysmenorrhoea and non-menstrual pelvic pain, classified by bleeding status, plus analgesic use.

Can visits be anchored to cycle events?

Yes. Visits can be anchored to an earlier visit, a milestone or a date entered on a form, such as the start of stimulation or embryo transfer, with windows around them.

Can participants complete daily diaries on their phones?

Yes, from a secure link with no app, with completion windows and reminders.

How is partner data handled?

Plan consent for each person whose data is collected, and define how partner and neonatal records link to the participant.

Can I try it free?

Yes, in the free sandbox with every feature.

Cycles, diaries and outcomes in one study

Anchored visits and daily diaries. Free sandbox.

Build your study free