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Follicle Stimulating Hormone

Follitropin Delta for Male Infertility

Phase 2

Recruiting

Research Sponsored by Ferring Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of infertility for 12-60 months with current partner at randomization

Current partner must be a pre-menopausal woman between the ages of 18 and 35 years

Must not have

Previous FSH treatment not leading to conception

Known history or presence of clinical varicocele

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to 21-35 days after end-of-treatment

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is investigating whether rFSH can improve the chance of spontaneous pregnancy in men with idiopathic infertility and their female partners.

Who is the study for?

This trial is for men aged 18-50 with unexplained infertility, having tried to conceive for 12-60 months. They must have a certain sperm count and quality, normal hormone levels, and agree to report on their partner's pregnancy status. Men with pituitary or testicular disorders, past cancer treatments affecting fertility, or recent use of certain medications are excluded.

What is being tested?

The trial tests if a daily dose of Follitropin Delta (rFSH) over six months improves the chances of spontaneous pregnancy in partners compared to a placebo. It measures the efficacy and safety of this treatment in increasing semen quality among men with idiopathic infertility.

What are the potential side effects?

While specific side effects are not listed here, rFSH treatments can generally include reactions at the injection site, headaches, mood changes, gynecomastia (breast growth in men), and potential impacts on fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been trying to conceive with my current partner for 1 to 5 years without success.

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My partner is a pre-menopausal woman aged 18-35.

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My partner has never had severe pelvic conditions or tubal ligation.

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I agree to try for a baby with my partner within 9 months of starting the study.

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I am a man aged between 18 and 50.

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My partner's menstrual cycle is regular, lasting 21-35 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tried FSH treatment for conception without success.

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I have been diagnosed with or have symptoms of varicocele.

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I have abnormalities in my vas deferens.

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I have a history of undescended testicles, twisted testicles, or testicle inflammation.

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I have a genetic abnormality involving the Y-chromosome.

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I have or had urogenital cancer and received treatments that may affect my testes.

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I have a hormone disorder that is not related to my reproductive organs and is not under control.

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I have a history of disorders in my pituitary gland or testes.

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I haven't taken any hormone treatments or drugs that could affect reproductive health in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to 21-35 days after end-of-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to 21-35 days after end-of-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 21-35 days after end-of-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Spontaneous pregnancy observed in female partner within 9 months after randomization of male subject, where spontaneous pregnancy is defined as vital pregnancy

Secondary study objectives

Changes in free testosterone concentration from randomization to 3 and 6 months after randomization

Immune-related adverse events

Treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity