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New IVF combo may boost fertility in older women

NCT ID NCT04719000

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a hormone called LH to standard IVF treatment helps women over 35 who had a low number of eggs in previous cycles. Participants will receive either the usual FSH hormone alone or FSH plus LH, and researchers will measure hormone levels on the day of egg retrieval. The goal is to see if the combination improves hormone balance and possibly pregnancy success.

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 120 people

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

Started

Feb 2021

Expected to finish

Nov 2027

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

35 to 40 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: * Able and willing to sign the Patient Consent Form and adhere to study visitation schedule. * ≥ 35 years ≤40 years old. * AFC ≥5 and or AMH ≥1.2 ng/mL. * \<4 or 4-9 oocytes retrieved in a previous IVF/ICSI cycle with a starting dose of ≤225 IU with any gonadotropin under a GnRH antagonist protocol. * Up to 3 previous ovarian stimulation cycles with a starting dose of ≤225 IU in which dose adjustments during stimulation did not exceed 300 IU. * Ovarian stimulation for IVF/ICSI Exclusion Criteria: * Poor ovarian responders according to the Bologna criteria. * Polycystic ovary syndrome (PCOS) patients according to the Rotterdam criteria. * AFC\>20. * Age \>40 or \<35 years old. * Women with \>10 oocytes retrieved in a previous IVF/ICSI cycle with 150-225 IU starting dose. * Women who required dose adjustments during stimulation \>300 IU with any gonadotropin in their previous cycle * Uterine abnormalities. * Recent history of any current untreated endocrine abnormality. * Unilateral or bilateral hydrosalpinx (visible on ultrasound scan (USS), unless clipped). * Contraindications for the use of medicine used for ovarian stimulation (gonadotropins, GnRH antagonist, progesterone vaginal gel) * Recent history of severe disease requiring regular treatment (Clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication to pregnancy). * Preimplantation Genetic Testing for Aneuploidies (PGT-a). * Testicular Sperm Aspiration or Testicular Sperm Extraction (TESA or TESE)

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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.

Infertility

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

  • Hospital Universitario Quiron Dexeus

    RECRUITING

    Barcelona, 08028, Spain

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