Male Idiopathic InfertilityPhase 2NCT05403476
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)
A Phase 2 study testing FE 999049 in people with Male Idiopathic Infertility, run by Ferring Pharmaceuticals at 22 sites in 7 countries.
Trial summary
The primary purpose of this trial is to investigate whether men with idiopathic infertility (unexplained reduction of semen quality), after being treated with a daily dose of 12 µg recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of spontaneous pregnancy observed in their female… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Male Idiopathic Infertility
- What is being tested?
- FE 999049
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 16 Aug 2022to 23 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States13 sites
Ferring Investigational Site
Bedford, Texas, 76022
Ferring Investigational Site
Centennial, Colorado, 80112
Ferring Investigational Site
Chicago, Illinois, 60612
Ferring Investigational Site
Kansas City, Kansas, 66160
Ferring Investigational Site
New York, New York, 10065
Ferring Investigational Site
Newark, Delaware, 19713
Ferring Investigational Site
Oklahoma City, Oklahoma, 73104
Ferring Investigational Site
Raleigh, North Carolina, 27607
Ferring Investigational Site
Salt Lake City, Utah, 84108
Ferring Investigational Site
San Jose, California, 95124
Ferring Investigational Site
Seattle, Washington, 98195
Ferring Investigational Site
Tempe, Arizona, 85284
Ferring investigational site
Webster, Texas, 77598
Germany2 sites
Ferring Investigational Site
Halle
Ferring Investigational Site
Münster
Italy2 sites
Ferring Investigational Site
Modena
Ferring Investigational Site
Rome
Sweden2 sites
Ferring Investigational Site
Malmö
Ferring Investigational Site
Stockholm
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of FE 999049 for Treatment of Men With Idiopathic Infertility
The primary purpose of this trial is to investigate whether men with idiopathic infertility (unexplained reduction of semen quality), after being treated with a daily dose of 12 µg recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of spontaneous pregnancy observed in their female partners in comparison to placebo (inactive treatment). For more information, please visit the trial's website www.adamclinicaltrial.com (only applicable in the US).
- Conditions
- Male Idiopathic Infertility
- Being tested
- FE 999049, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FE 999049Drug
Also called REKOVELLE, Follitropin Delta
FE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months.
PlaceboDrug
Placebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| FE 999049 (Follitropin Delta) | Experimental | Not described Receives: Drug: FE 999049 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Pregnancy Observed in Female Partner Within 9 Months After Randomization of Male Subject, Where Spontaneous Pregnancy is Defined as Vital Pregnancy
Vital pregnancy is documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound.
Measured: Up to 9 months after randomization
Secondary outcomes (17)
Positive Beta-Human Chorionic Gonadotropins (βhCG) (Positive Urine βhCG Test) Observed in Female Partner
Measured: Up to 9 months (End-of-Trial)
Time From Randomization to Spontaneous Pregnancy Observed in Female Partner.
Measured: 9 months
Changes in Semen Volume From Pre-randomisation to 9 Months After Randomization
Change from baseline pre-randomisation to end of trial, which is 9 months.
Measured: From pre-randomisation to end of trial (9 months)
Changes in Sperm Concentration
Change from baseline from pre-randomisation to end of trial, which is 9 months
Measured: From pre-randomization to end of trial (9 months)
Changes in Total Sperm Count
Change from baseline from pre-randomisation to end of trial, which is 9 months
Measured: From pre-randomisation to end of trial (9 months)
Changes in Total Motile Sperm Count
Change from baseline from pre-randomisation to end of trial, which is 9 months
Measured: From pre-randomisation to end of trial (9 months)
Changes in Sperm Morphology
Change from baseline from pre-randomisation to end of trial, which is 9 months
Measured: From pre-randomisation to end of trial (up to 9 months)
Changes in Semen DNA Fragmentation
Measured: From pre-randomization to end of treatment
Treatment Responders Defined by Either Spontaneous Pregnancy Observed in Female Partner, or Increase of Total Sperm Count or Total Motile Sperm Count to 50% Over Average Baseline at 6 and/or 9 Months
Measured: Baseline to 6 and 9 months
Changes in Follicle Stimulating Hormone (FSH)
Change from baseline.
Measured: From randomization to 6 months after randomization
Changes in Luteinising Hormone (LH)
From randomisation to 3 and 6 months
Measured: From randomisation to 3 and 6 months after randomization
Changes in Inhibin B
Change from baseline.
Measured: From randomization to 6 months after randomization
Changes in Testosterone
Change from baseline.
Measured: From randomization to 6 months after randomization
Changes in Estradiol
Change from baseline.
Measured: From randomization to 6 months after randomization
Changes in Free Testosterone Concentration
Blood samples for assessment of sex hormone binding globulin (SHBG) concentrations will be drawn in order to calculate change from baseline in free testosterone concentrations.
Measured: From randomization to 6 months after randomization
Number of Participants With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity
Blood samples for assessment of anti-FSH antibodies will be drawn.
Measured: From randomization to 21-35 days after End-of-treatment (9 months)
Number of Participants With Immune-related Adverse Events
All treatment-emergent adverse events will be analyzed to identify those that potentially are immune related.
Measured: From randomization to End-of-Trial (up to 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start16 Aug 2022
- Primary completion5 Oct 2024
- Study completion23 Oct 2024
Why it stopped: The probability of enrolling subjects in the trial in a reasonable timeframe was too low. The termination was not due to safety concerns nor changes in Ferring's Reproductive Medicine strategy or interest in developing treatments for Male Infertility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Male Idiopathic InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403476
- Sponsor's protocol ID
- 000400
- Status last verified
- Aug 2026
- First submitted
- 30 May 2022
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of FE 999049 for Treatment of Men With Idiopathic Infertility
- ClinicalTrials.gov ID
- NCT05403476
- Acronym / sponsor ID
- 000400
- Conditions
- Male Idiopathic Infertility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The probability of enrolling subjects in the trial in a reasonable timeframe was too low. The termination was not due to safety concerns nor changes in Ferring's Reproductive Medicine strategy or interest in developing treatments for Male Infertility
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Posted 28 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this trial is to investigate whether men with idiopathic infertility (unexplained reduction of semen quality), after being treated with a daily dose of 12 µg recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of spontaneous pregnancy observed in their female partners in comparison to placebo (inactive treatment). For more information, please visit the trial's website www.adamclinicaltrial.com (only applicable in the US).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FE 999049 (Follitropin Delta) | Experimental | Drug: FE 999049 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FE 999049Also: REKOVELLE, Follitropin DeltaFE 999049 is administered as single daily subcutaneous injections of 12 μg for 6 months. | Drug | FE 999049 (Follitropin Delta) |
| PlaceboPlacebo is administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049 for 6 months. | Drug | Placebo |
Primary outcome
Spontaneous Pregnancy Observed in Female Partner Within 9 Months After Randomization of Male Subject, Where Spontaneous Pregnancy is Defined as Vital Pregnancy
Time frame: Up to 9 months after randomization
Vital pregnancy is documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound.
17 secondary outcomes
Positive Beta-Human Chorionic Gonadotropins (βhCG) (Positive Urine βhCG Test) Observed in Female Partner
Time frame: Up to 9 months (End-of-Trial)
Time From Randomization to Spontaneous Pregnancy Observed in Female Partner.
Time frame: 9 months
Changes in Semen Volume From Pre-randomisation to 9 Months After Randomization
Time frame: From pre-randomisation to end of trial (9 months)
Changes in Sperm Concentration
Time frame: From pre-randomization to end of trial (9 months)
Changes in Total Sperm Count
Time frame: From pre-randomisation to end of trial (9 months)
Changes in Total Motile Sperm Count
Time frame: From pre-randomisation to end of trial (9 months)
Changes in Sperm Morphology
Time frame: From pre-randomisation to end of trial (up to 9 months)
Changes in Semen DNA Fragmentation
Time frame: From pre-randomization to end of treatment
Treatment Responders Defined by Either Spontaneous Pregnancy Observed in Female Partner, or Increase of Total Sperm Count or Total Motile Sperm Count to 50% Over Average Baseline at 6 and/or 9 Months
Time frame: Baseline to 6 and 9 months
Changes in Follicle Stimulating Hormone (FSH)
Time frame: From randomization to 6 months after randomization
Changes in Luteinising Hormone (LH)
Time frame: From randomisation to 3 and 6 months after randomization
Changes in Inhibin B
Time frame: From randomization to 6 months after randomization
Changes in Testosterone
Time frame: From randomization to 6 months after randomization
Changes in Estradiol
Time frame: From randomization to 6 months after randomization
Changes in Free Testosterone Concentration
Time frame: From randomization to 6 months after randomization
Number of Participants With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity
Time frame: From randomization to 21-35 days after End-of-treatment (9 months)
Number of Participants With Immune-related Adverse Events
Time frame: From randomization to End-of-Trial (up to 9 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FE 999049 in people with Male Idiopathic Infertility, run by Ferring Pharmaceuticals at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Germany, Italy, Sweden, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous Pregnancy Observed in Female Partner Within 9 Months After Randomization of Male Subject, Where Spontaneous Pregnancy is Defined as Vital Pregnancy (time frame: Up to 9 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.