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New drug combo aims to boost IVF success for women with hormone deficiency

NCT ID NCT07340827

Disease control Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This Phase 3 trial tests a new combination of two hormones (follitropin alfa and lutropin alfa) against a standard treatment (hMG) for Japanese women with LH and FSH deficiency who are undergoing IVF. The goal is to see which treatment helps produce more eggs for retrieval. About 266 women will participate, and the study lasts up to 13 months for those who become pregnant.

What this could mean

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

Active substance
follitropin alfa and lutropin alfa (a combination of two hormones to stimulate egg growth)
What this could lead to
If this works, it could offer a more effective fertility treatment option for Japanese women with hormone deficiencies who need IVF.
What could go wrong
This is a Phase 3 trial, but it is still experimental. The new drug may not work better than the existing treatment, and side effects like ovarian hyperstimulation are possible.

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 266 people

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

Started

Feb 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 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: * Participants who are premenopausal wishing to conceive * Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy * Japanese Participants * Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency congenital or acquired * Participants have a vaginal ultrasound scan showing both ovaries and no clinically significant uterine abnormality and a normal antral follicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) in diameter per ovary * A semen analysis of the male partner been performed within 3 months prior to signature of informed consent and suitable for assisted reproductive technology * Participants have a normal cervical ThinPrep® cytologic test, (TCT) or Pap smear within 12 months of Screening. If not available, a cervical smear will be performed as part of screening * Other protocol defined criteria may apply Exclusion Criteria: * Participants with history of severe OHSS in any previous ovarian stimulation cycle * Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modified definition * Participants with contraindication to treatment with gonadotropins, hypersensitivity to gonadotropins or to any of the excipients * Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, or mammary carcinoma) * Participants with ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 millimeters before Day 1 * other protocol defined exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

hypogonadotropic hypogonadism hypogonadotropic hypogonadism 24 without anosmia infertility disorder

As listed by the trial registrant

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

Infertility

How to take part

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

  1. The places running it

    21 sites. 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

  • Akita University Hospital - Dept of Obstetrics/Gynecology

    RECRUITING

    Akita, Akita, 010-8543, Japan

  • Dokkyo Medical University Hospital - Dept of Reproduction Center

    RECRUITING

    Shimotsuga-gun, Tochigi, 321-0293, Japan

  • Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology

    RECRUITING

    Kobe, Hyōgo, 650-0021, Japan

  • Haruki Ladies Clinic - Dept of Gynecology

    RECRUITING

    Osaka, Osaka, 542-0081, Japan

  • JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology

    RECRUITING

    Nagano, Nagano, 388-8004, Japan

  • Juntendo University Hospital - Dept of Obstetrics/ Gynecology

    RECRUITING

    Bunkyō City, Tokyo-To, 113-8431, Japan

  • KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology

    RECRUITING

    Saitama-shi, Saitama, 330-0855, Japan

  • Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology

    RECRUITING

    Chiba, Chiba, 261-8501, Japan

  • Kamiya Ladies Clinic - Dept of Gynecology

    RECRUITING

    Sapporo, Hokkaido, 060-0003, Japan

  • Ladies Clinic Cosmos - Dept of Infertility Treatment

    RECRUITING

    Kochi, Kochi, 780-0072, Japan

  • Nagano Municipal Hospital - Dept of Gynecology

    RECRUITING

    Nagano, Nagano, 381-8551, Japan

  • Omiya Ladies Clinic - Dept of Gynecology

    RECRUITING

    Saitama-shi, Saitama, 330-8669, Japan

  • Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology

    RECRUITING

    Higashiosaka-shi, Osaka, 577-0012, Japan

  • Sophia Ladies Clinic - Dept of Obstetrics/Gynecology

    RECRUITING

    Sagamihara-shi, Kanagawa, 252-0233, Japan

  • Sora no Mori Clinic - Dept of Obstetrics/Gynecology

    RECRUITING

    Shimajiri-gun, Okinawa, 901-0406, Japan

  • Sugiyama Clinic Marunouchi - Dept of Obstetrics/ Gynecology

    RECRUITING

    Chiyoda-ku, Tokyo-To, 100-0005, Japan

  • Sugiyama Clinic Shinjuku - Dept of Reproductive Medical

    RECRUITING

    Shinjuku-ku, Tokyo-To, 160-0023, Japan

  • Toho University Omori Medical Center - Dept of Obstetrics/Gynecology

    RECRUITING

    Ōta-ku, Tokyo-To, 143-8541, Japan

  • Tokushima University Hospital - Dept of Obstetrics/Gynecology

    RECRUITING

    Tokushima, Tokushima, 770-8503, Japan

  • University of Tokyo Hospital - Dept of Obstetrics

    RECRUITING

    Bunkyō City, Tokyo-To, 113-8655, Japan

  • YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology

    RECRUITING

    Maebashi, Gunma, 371-0031, Japan

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