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A Hormone's hidden power: could progesterone be the key to unexplained infertility?

NCT ID NCT07738068

Disease control Sponsor: Simone Broer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This phase 3 trial investigates whether taking progesterone during the luteal phase of the menstrual cycle can increase the chance of a live birth for couples with unexplained infertility. Participants take either progesterone or a placebo twice daily for up to six months while tracking their cycles at home. The study aims to answer whether this simple hormone support can make a difference when no other cause for infertility is found.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
progesterone (Utrogestan 200 mg soft capsules)
What this could lead to
If effective, progesterone could offer a simple, low-cost treatment to improve pregnancy chances for couples with unexplained infertility.
What could go wrong
This is a phase 3 trial, but previous smaller studies have shown mixed results. Progesterone may not increase live birth rates and could cause side effects like drowsiness or bloating.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 640 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 43 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

female infertility infertility disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Female infertility Infertility Infertility primary Infertility secondary Subfertility Subfertility, female

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.