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Can a daily hormone shot boost natural pregnancy in couples with unexplained male infertility?

NCT ID NCT05403476

Disease control Sponsor: Ferring Pharmaceuticals 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether a daily injection of the hormone FE 999049, given to men with unexplained infertility for 6 months, can increase the chance of their partners becoming pregnant naturally. Men aged 18 to 50 with low but not absent sperm counts and a history of infertility with their partner may join. Half receive the hormone and half receive a placebo, and researchers track pregnancies and sperm changes over 9 months.

What this could mean

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

Active substance
FE 999049 (follitropin delta), a recombinant follicle-stimulating hormone given as daily injections for 6 months
What this could lead to
If it works, this could offer a new treatment option for men with unexplained infertility, potentially increasing the chance of natural pregnancy for their partners.
What could go wrong
This is an early-phase trial with only 4 participants, so results may not apply broadly. The hormone may not improve fertility, and daily injections carry risks like injection-site reactions or hormonal side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

4 people

The number who actually took part.

Started

Aug 2022

Finished

Oct 2024

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 50 years

Sex

Male 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: * History of infertility with current partner at randomisation must be 12-60 months if current partner is aged \<35 years or 6-60 months if current partner is aged 35-38 years. * Men between the ages of 18 and 50 years. * Total sperm count 5-39 million at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomization. * Total sperm motility of ≥10% at screening; confirmed by two samples taken ≥2 weeks apart before randomisation. If a semen sample has been taken within 3 months prior to screening and been analysed at an andrology laboratory, it can be included as the first of the two semen samples at screening. * Semen volume ≥1.4 mL at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomization. * Serum follicle-stimulating hormone (FSH) levels of 2-12.0 IU/L (measured at central laboratory) at screening) * Serum luteinising hormone (LH) levels of 1.2-7.5 IU/L (measured at central laboratory) at screening. * Serum total testosterone levels of ≥300 ng/dL (equals ≥10.4 nmol/L; measured at central laboratory) at screening. * Agree to have regular intercourse with current female partner with the intent of spontaneous conception within 9 months from randomization. * Agree to provide information on female partner's positive urine pregnancy test(s) and documentation of ultrasound(s), delivery, and neonatal/infant health. Current partner fulfilling the criteria below: * Pre-menopausal woman between the ages of 18 and 38 years (both inclusive) at the time of randomisation of male participant. * Regular menstrual cycles of 21-35 days. * No history or current condition of pelvic inflammatory disease, endometriosis stage II-IV by definite or empirical diagnosis, or tubal ligation. * Agree not to obtain infertility treatment outside of this trial for 6 months from randomization of male subject. Exclusion Criteria: * Previous FSH treatment for ≥4 months not leading to conception. * Past or current use of finasteride within 3 months prior to screening. * Any history of anatomical disorder of the pituitary gland or testes. * Any structural abnormalities of the vas deferens (unilateral or bilateral) at screening. * Any known, clinically significant, systemic disease in addition to the trial indication that might negatively impact fertility. * Known history or presence of clinical varicocele (subclinical and Grade 1 varicocele are acceptable). * Known history of cryptorchidism, testicular torsion, or orchitis. * Known abnormal karyotype (including Y-chromosome microdeletion). * Current or past treatment of urogenital (kidney, bladder, testicular, or prostate) cancer as well as history of chemo- or radiotherapy that can have impact on testes. * Any known uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders). * Administration of hormonal preparations, agents known to impair testicular function or affect sex hormone secretion, and known or suspected teratogens within 3 months prior to screening. Administration of anabolic steroids within 12 months prior to screening.

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As listed by the trial registrant

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

Male idiopathic infertility

Contacts and locations

Locations

  • Ferring Investigational Site

    Tempe, Arizona, 85284, United States

  • Ferring Investigational Site

    San Jose, California, 95124, United States

  • Ferring Investigational Site

    Centennial, Colorado, 80112, United States

  • Ferring Investigational Site

    Newark, Delaware, 19713, United States

  • Ferring Investigational Site

    Chicago, Illinois, 60612, United States

  • Ferring Investigational Site

    Kansas City, Kansas, 66160, United States

  • Ferring Investigational Site

    New York, New York, 10065, United States

  • Ferring Investigational Site

    Raleigh, North Carolina, 27607, United States

  • Ferring Investigational Site

    Oklahoma City, Oklahoma, 73104, United States

  • Ferring Investigational Site

    Bedford, Texas, 76022, United States

  • Ferring Investigational Site

    Salt Lake City, Utah, 84108, United States

  • Ferring Investigational Site

    Seattle, Washington, 98195, United States

  • Ferring Investigational Site

    Brussels, Belgium

  • Ferring Investigational Site

    Copenhagen, Denmark

  • Ferring Investigational Site

    Halle, Germany

  • Ferring Investigational Site

    Münster, Germany

  • Ferring Investigational Site

    Modena, Italy

  • Ferring Investigational Site

    Rome, Italy

  • Ferring Investigational Site

    Valencia, Spain

  • Ferring Investigational Site

    Malmö, Sweden

  • Ferring Investigational Site

    Stockholm, Sweden

  • Ferring investigational site

    Webster, Texas, 77598, United States