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Could a lighter touch in IVF yield healthier embryos for women over 35?

NCT ID NCT06154083

Disease control Sponsor: Fundación Santiago Dexeus Font Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether a lower daily dose of the fertility drug Rekovelle can produce as many healthy embryos as a higher dose in women of advanced age undergoing IVF with genetic screening. Participants receive either 15 or 20 micrograms per day during ovarian stimulation. Researchers then compare the number of normal embryos and hormone levels between the two groups.

What this could mean

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

Active substance
Follitropin-delta (Rekovelle), a hormone injection used to stimulate the ovaries
What this could lead to
If a milder stimulation works as well as a stronger one, it could reduce side effects and costs while maintaining or improving the chance of a healthy embryo in older women.
What could go wrong
This is a phase 4 trial with 110 participants, so results may not apply to all patients. The milder dose might produce fewer eggs, and the study does not yet prove live birth 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 110 people

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

Started

Dec 2023

Expected to finish

Dec 2026

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

38 to 42 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: * Infertile patients with indication for IVF * Undergoing preimplantation genetic screening cycles * AMH \>= 1.5 ng/ml and \< 3.5 ng/ml (AMH result of up to one year will be valid) * BMI 18.5 - 30 Kg/m2 Exclusion Criteria: * Severe male factor requiring TESE (testicular sperm extraction) * AMH \< 1.5 ng/ml or \>= 3.5 ng/ml * Administration of any other drug potentially interfering with the treatment * Contraindication for hormonal treatment * Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment). * Monogenic disease to be detected with PGT-M

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Conditions

The condition(s) this trial relates to.

infertility disorder

As listed by the trial registrant

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

Fertility

How to take part

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

  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

    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.

Contacts and locations

Locations

  • Hospital Universitario Quiron Dexeus

    RECRUITING

    Barcelona, 08028, Spain

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