Not Yet RecruitingPhase 3

Progesterone Luteal Support in Unexplained Infertility Management

640 participantsStarted 2026-08-01

Plain-language summary

The purpose of this study is to evaluate whether progesterone in women with unexplained infertility can increases live birth rate. The main research question is: Does luteal phase support with progesterone increase the live birth rate among couples with unexplained infertility? The study compares progesterone with placebo to determine the effectiveness of progesterone in unexplained infertility. Study participants will: * Perform home ovulation tests and maintain a digital diary to record menstrual cycles and study medication use.10 * Take progesterone or placebo twice daily during the luteal phase of each menstrual cycle for up to six months.11 * Continue usual medical care. No additional hospital visits or invasive procedures are required as part of the study.

Who can participate

Age range

18 Years – 43 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Primary or secondary infertility for at least a period of 1 year Participants whose previous pregnancy was achieved through MOH-IUI or IVF are eligible to join the study, provided they are willing to continue expectant management for at least six months before considering any further fertility interventions * Diagnosis of UI after infertility work-up, i.e. * regular menstrual cycle ranging between 21-35 days, * total motile sperm count ≥ 10 million/ml, * no risk of tubal pathology (or in case of increased risk, tubal pathology uitgesloten middels tubal patency testing) * A Hunault prognostic score ≥ 30% (calculated using the Hunault prediction model7, based on key prognostic factors including female age, subfertility duration, type of subfertility (primary or secondary), sperm motility and referral status), * Assignment to expectant management during at least six months, in accordance with Dutch NVOG Guidelines (4). * Female age ≥18 years old Female * BMI \<45 kg/m2 Exclusion Criteria: * Uncorrected uterine factors, such as endometrial polyps or submucosal fibroids, * Insufficient knowledge or understanding of the Dutch or English language and not willing or able to receive study information via a certified translator * Not able or willing to provide (written) informed consent * Contraindications for vaginal progesterone, in particular: females with allergy to peanuts or soya. * Formal diagnosis of endometriosis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pregnancy occurring within 6 months after randomisation, leading to a live birth.

Timeframe: within 6 months after randomisation

Trial details

NCT IDNCT07738068

SponsorSimone Broer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-08-01

Contact for this trial

Julie C.M. van de Wal, MD

+31650177981 j.c.m.vandewal-15@umcutrecht.nl

View on ClinicalTrials.gov More Infertility trials