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Can extra progesterone boost IVF success? new trial investigates

NCT ID NCT07613528

Disease control Sponsor: University Hospital, Montpellier 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether giving daily progesterone injections for 6 weeks after a positive pregnancy test can improve live birth rates in women with low progesterone levels. The study includes 214 women aged 18-37 who became pregnant through IVF. Half will receive the extra progesterone shots, and half will receive placebo injections, with neither the patients nor doctors knowing who gets what.

What this could mean

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

Active substance
Progesterone (injectable and vaginal)
What this could lead to
If successful, this could show that extending progesterone shots for 6 weeks after a positive pregnancy test increases the chance of a live birth in women with low progesterone levels.
What could go wrong
This is a relatively small trial (214 participants) and only includes women aged 18-37 with specific progesterone levels, so results may not apply to everyone. The extra injections may cause discomfort or side effects without improving outcomes.

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 214 people

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

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Sep 2030

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 37 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: * Patient aged 18 to 37 year-old; * Patients with a BMI below 34 kg/m2; * After a fresh embryo transfer following an ovarian hyperstimulation for an IVF with a luteal phase support based on micronized vaginal progesterone; * With a positive pregnancy test (β-hCG \> 100 UI/L); * With a serum progesterone level below 17 ng/mL on the day of pregnancy test; * Patient able to self-administer subcutaneous progesterone injections, either alone or with the help of her partner. Exclusion Criteria: * Patient undertaking an additional source of progesterone (oral or injected) or a treatment stimulating endogenous progesterone secretion (such as Gonadotropin-Releasing Hormone: GnRH agonist, or chorionique gonadotropic hormone: hCG injections); * Patients with intolerance or contraindication to subcutaneous progesterone administration; * Patients with a known 21-hydroxylase deficiency; * Patients with uterine pathology or untreated hydrosalpinx; * Patients with a history of recurrent miscarriages (3 or more); * Patient undergoing pre-implantation genetic testing; * Patient unavailable or unwilling to participate in future visits or is unable to comply with trial protocol; * Subjects unable to read or/and write French; * Failure to obtain the consent; * Subjects non-beneficiary of the French social security (Government medical aid (AME) excluded); * Subjects placed under legal protection, under guardianship or under curatorship; * Patient in an exclusion period determined by a previous study; * Subjects participating in another interventional research.

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As listed by the trial registrant

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

Low serum progesterone Pregnancy Progesterone supplementation

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • CHU de Montpellier

    Montpellier, 34295, France

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