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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).
EU CTIS ID: 2023-508430-34-00
What this study is testing
To investigate the effect of FE 999049 treatment of men with idiopathic infertility on the chance of spontaneous pregnancy in their female partners.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- History of infertility for 12-60 months with current partner at randomisation
- 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: a) Pre-menopausal woman between the ages of 18 and 35 years. b) Regular menstrual cycles of 21-35 days. c) No history or current condition of pelvic inflammatory disease, endometriosis stage II-IV by definite or empirical diagnosis, or tubal ligation. d) Agree not to obtain infertility treatment outside of this trial for 9 months from randomisation of male subject.
- 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 randomisation
- Total sperm motility of ≥10% at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomisation
You likely can't join if
- Previous FSH treatment not leading to conception
- 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
- 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
See the full eligibility criteria
- History of infertility for 12-60 months with current partner at randomisation
- 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: a) Pre-menopausal woman between the ages of 18 and 35 years. b) Regular menstrual cycles of 21-35 days. c) No history or current condition of pelvic inflammatory disease, endometriosis stage II-IV by definite or empirical diagnosis, or tubal ligation. d) Agree not to obtain infertility treatment outside of this trial for 9 months from randomisation of male subject.
- 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 randomisation
- Total sperm motility of ≥10% at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomisation
- Semen volume ≥1.4 mL at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomisation
- Serum follicle-stimulating hormone (FSH) levels of 1.5-8.0 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 randomisation
- Previous FSH treatment not leading to conception
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.