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.
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Daily pelvic pain diary
Tuesday · Day 17 of cycle
Bleeding today
Worst pelvic pain in the last 24 hours
Pain medication taken
What matters in reproductive health trials
Study design
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.
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.
Weeks
Daily diaries
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.
At-risk participants
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Endpoints
| Condition | Typical endpoints | Data needed |
|---|---|---|
| Infertility (IVF, ovulation induction) | Live birth, clinical and ongoing pregnancy, pregnancy loss | Cycle forms, ultrasound results, pregnancy and delivery follow-up |
| Endometriosis | Dysmenorrhoea and non-menstrual pelvic pain responders, dyspareunia, quality of life | Daily pain and bleeding diary, analgesic use, questionnaires |
| PCOS | Ovulation, menstrual cyclicity, hirsutism score, metabolic measures | Cycle records, hormone and metabolic labs, clinician ratings |
| Heavy menstrual bleeding | Menstrual blood loss, bleeding days | Bleeding diaries or product collection methods |
Safety and follow-up
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
Stimulation start, transfer or cycle day defined for visit timing.
Live birth, clinical pregnancy and loss defined per protocol.
Consent and record linkage planned.
Pain, bleeding and analgesic fields matched to endpoints.
OHSS grading, bone density or labs as needed.
Contact details and ascertainment plan for pregnancy outcomes.
Live birth is increasingly recommended, rather than pregnancy tests or clinical pregnancy alone.
Usually with daily ratings of dysmenorrhoea and non-menstrual pelvic pain, classified by bleeding status, plus analgesic use.
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.
Yes, from a secure link with no app, with completion windows and reminders.
Plan consent for each person whose data is collected, and define how partner and neonatal records link to the participant.
Yes, in the free sandbox with every feature.
Anchored visits and daily diaries. Free sandbox.