Follitropin Alfa for Male Infertility

Overseen By Communication Center

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: EMD Serono Research & Development Institute, Inc.

Must not be taking: Testosterone, Antidepressants, Antipsychotics, others

Disqualifiers: Cardiovascular events, Tumors, Smokers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two forms of follitropin alfa, a hormone treatment, compare in addressing male infertility. The researchers aim to determine if the test version of the drug is as effective as the current standard version. Participants will receive both forms of the medication in different sequences. The trial seeks healthy men with normal testosterone levels who do not smoke. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial, especially if they increase testosterone levels or affect heart rhythm. It's best to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that follitropin alfa, a treatment for male infertility, is generally safe and well-tolerated. In past studies, patients using follitropin alfa reported no major side effects. For instance, one study found that men with a specific type of infertility, called IHH, tolerated the treatment well when combined with another hormone, hCG. Another study indicated that follitropin alfa was safe for long-term use in men who did not produce sperm.

Overall, follitropin alfa has a good safety record for men dealing with infertility. This suggests it is generally safe for those considering joining a clinical trial involving this treatment. However, as with any medical treatment, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Follitropin Alfa is unique because it specifically targets male infertility by stimulating sperm production, which is a different approach compared to conventional treatments like hormone therapy or lifestyle changes. Researchers are excited about this treatment because it uses a recombinant form of the follicle-stimulating hormone (FSH), which is bioidentical to the naturally occurring hormone in the body, potentially leading to more effective and consistent results. Unlike traditional therapies, Follitropin Alfa provides a more precise method of addressing hormonal deficiencies, offering hope for improved fertility outcomes in men.

What evidence suggests that follitropin alfa might be an effective treatment for male infertility?

Research has shown that follitropin alfa can improve male fertility by boosting sperm production in men who struggle with sperm development. One study demonstrated that long-term treatment with follitropin alfa and another hormone (hCG) helped men produce sperm. Another study found that 63.2% of men experienced a significant increase in sperm concentration. Overall, follitropin alfa has proven effective and well-tolerated for increasing sperm count and movement, both crucial for male fertility. Participants in this trial will receive either test follitropin alfa followed by reference follitropin alfa, or reference follitropin alfa followed by test follitropin alfa, to evaluate its effectiveness and safety. ^{4 6 7 8 9}

Who Is on the Research Team?

Medical Responsible

Principal Investigator

EMD Serono Research & Development Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy males with conditions like male infertility, hypogonadotropic hypogonadism, or low testosterone. Participants will undergo a downregulation period before being randomly assigned to receive either the test drug (follitropin alfa solution in pen) or the reference drug (follitropin alfa powder in vial).

Inclusion Criteria

Have a normal baseline testosterone level

I am generally healthy based on recent medical exams and tests.

Other protocol defined inclusion criteria could apply

Exclusion Criteria

Smokers

Other protocol defined exclusion criteria could apply

I have had tumors in my pituitary gland or hypothalamus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Downregulation

Participants undergo a downregulation period to prepare for treatment

2 weeks

Treatment Period 1

Participants receive either Test or Reference follitropin alfa

2 weeks

Treatment Period 2

Participants receive the alternate treatment (Reference or Test) follitropin alfa

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Follitropin Alfa

Trial Overview The study aims to compare two forms of follitropin alfa: an injectable solution in a prefilled pen ('Test') and a powder form that's mixed into a solution ('Reference'). Each participant will try both forms over two periods, totaling up to about 9 weeks.

How Is the Trial Designed?

Group I: Sequence 2 Experimental Treatment 3 Interventions

Participants will receive reference follitropin alfa in Period 1 followed by test follitropin alfa in Period 2.

Group II: Sequence 1 Experimental Treatment 3 Interventions

Participants will receive Test follitropin alfa in Period 1 followed by Reference follitropin alfa in Period 2.

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials

86

Recruited

22,700+

Miguel Fernández Alcalde

EMD Serono Research & Development Institute, Inc.

Chief Executive Officer

Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School

Danny Bar-Zohar

EMD Serono Research & Development Institute, Inc.

Chief Medical Officer since 2022

MD

Merck KGaA, Darmstadt, Germany

Industry Sponsor

Trials

449

Recruited

122,000+

Danny Bar-Zohar

Merck KGaA, Darmstadt, Germany

Chief Medical Officer since 2022

MD

Belén Garijo

Merck KGaA, Darmstadt, Germany

Chief Executive Officer since 2021

MD

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6944427/

Efficacy of follitropin-alpha versus human menopausal ... They showed that the rate of sperm appearance in the ejaculate was 77%, 81%, and 84% for patients who underwent urinary, highly purified, and recombinant FSH, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0015028208032615

Stimulation of spermatogenesis with recombinant human ... Long-term treatment of azoospermic HH men using follitropin alfa and hCG is effective for stimulating spermatogenesis and is well-tolerated.

3. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2019.00322/full

Clinical Use of FSH in Male Infertility Most relevant, the pregnancy rate of 62% was higher in patients with post-pubertally acquired hypogonadotropic hypogonadism compared with those ...

4. fertstert.org fertstert.org/article/S0015-0282(01)02973-9/fulltext

Efficacy and safety of recombinant human follicle- ... Twelve of 19 (63.2%) eligible patients achieved a sperm concentration of 1.5 × 106/mL, three (15.8%) achieved a sperm concentration of 1.0 × 106/mL, and four ...

5. journals.lww.com journals.lww.com/cur/fulltext/2025/05000/effectiveness_of_recombinant_follicle_stimulating.10.aspx

Effectiveness of recombinant follicle-stimulating hormone... Follicle-stimulating hormone treatment improves sperm concentration and motility in men with oligo-asthenospermia, with significant improvements observed in men ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11821082/

Efficacy and safety of recombinant human follicle- ... Conclusion(s): With hCG, rhFSH is effective in initiating spermatogenesis in patients with IHH, and is well tolerated. Publication types. Clinical Trial ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0015028208014957

A combined analysis of data to identify predictive factors for ... A combined analysis of data from four clinical trials was performed to evaluate the efficacy and safety of r-hFSH (follitropin alfa) in combination with hCG ( ...

8. fertstert.org fertstert.org/article/S0015-0282(08)03261-5/fulltext

GONAL-f®): long-term treatment in azoospermic men with ... Conclusion(s). Long-term treatment of azoospermic HH men using follitropin alfa and hCG is effective for stimulating spermatogenesis and is well-tolerated.

9. mdpi.com mdpi.com/2075-1729/14/8/969

FSH Therapy in Male Factor Infertility: Evidence and ... The effects of recombinant and purified FSH (biosimilars and originators) appear to be similar, being well tolerated and safe [13]. FSH is often used in ...