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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 and 9 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 and 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 and 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Changes in estradiol from randomization to 3 and 6 months after randomization

Changes in follicle stimulating hormone (FSH) from randomization to 3 and 6 months after randomization

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

+14 more

Side effects data

From 2013 Phase 2 trial • 265 Patients • NCT01426386

Pelvic pain

Abortion spontaneous

Headache

Vaginal haemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

GONAL-F 11 µg

FE 999049 10.3 µg

FE 999049 12.1 µg

FE 999049 8.6 µg

FE 999049 6.9 µg

FE 999049 5.2 µg

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FE 999049 (Follitropin Delta)Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Follitropin

FDA approved

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ferring PharmaceuticalsLead Sponsor

313 Previous Clinical Trials

440,458 Total Patients Enrolled

59 Trials studying Infertility

31,800 Patients Enrolled for Infertility

Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals

62 Previous Clinical Trials

356,995 Total Patients Enrolled

15 Trials studying Infertility

16,157 Patients Enrolled for Infertility

Media Library

Follitropin Delta (Follicle Stimulating Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT05403476 — Phase 2

Infertility Research Study Groups: FE 999049 (Follitropin Delta), Placebo

Infertility Clinical Trial 2023: Follitropin Delta Highlights & Side Effects. Trial Name: NCT05403476 — Phase 2

Follitropin Delta (Follicle Stimulating Hormone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05403476 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health risks have been associated with the use of FE 999049?

"Our team at Power rated FE 999049 a 2, considering there is only limited data confirming its safety and none that validates its efficacy."

Answered by AI

Are there any opportunities presently available to participate in this investigation?

"According to the latest data posted on clinicaltrials.gov, this trial is currently in search of participants with an initial posting date of August 16th 2022 and a most recent update occurring November 15th 2022."

Answered by AI

Is participation in this research opportunity open to octogenarians?

"This trial seeks those aged 18 and above but below the age of 50 for enrolment."

Answered by AI

What is the geographical scope of this clinical investigation?

"The present medical experiment is being administered through 8 different clinics, situated in Chicago, Greenwood Village and Seattle among other cities. One should select the nearest clinic to reduce travel requirements if they decide to partake."

Answered by AI

Who fulfills the qualifications for participating in this clinical experiment?

"This clinical trial is recruiting 400 male candidates with idiopathic infertility, aged between 18 and 50 years old. To be eligible for inclusion in the study, applicants must have serum testosterone levels of 10.4 nmol/L or higher; plan to engage in regular intercourse with their current partner over the next nine months with intent towards natural conception; provide information on any female partners' pregnancy tests and ultrasounds; have a history of infertility between one year and five years long at time of randomization; possess total sperm count within 5-39 million range verified by two consecutive samples taken no less than two weeks apart prior to randomization,"

Answered by AI

What is the projected size of this clinical trial's participant pool?

"Yes, according to the information listed on clinicaltrials.gov this research project is still open for participants. The trial was established on August 16th 2022 and last updated November 15th 2022 with the aim of recruiting 400 volunteers from 8 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)

2022. "A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05403476.

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