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)
- Conditions
- Male Idiopathic Infertility
- Registration Number
- NCT05403476
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 400
Inclusion Criteria:<br><br> - History of infertility with current partner at randomisation must be 12-60 months if<br> current partner is aged <35 years or 6-60 months if current partner is aged 35-38<br> years.<br><br> - Men between the ages of 18 and 50 years.<br><br> - Total sperm count 5-39 million at screening; confirmed by two consecutive samples<br> taken =2 weeks apart before randomization.<br><br> - Total sperm motility of =10% at screening; confirmed by two samples taken =2 weeks<br> apart before randomisation. If a semen sample has been taken within 3 months prior<br> to screening and been analysed at an andrology laboratory, it can be included as the<br> first of the two semen samples at screening.<br><br> - Semen volume =1.4 mL at screening; confirmed by two consecutive samples taken =2<br> weeks apart before randomization.<br><br> - Serum follicle-stimulating hormone (FSH) levels of 2-12.0 IU/L (measured at central<br> laboratory) at screening)<br><br> - Serum luteinising hormone (LH) levels of 1.2-7.5 IU/L (measured at central<br> laboratory) at screening.<br><br> - Serum total testosterone levels of =300 ng/dL (equals =10.4 nmol/L; measured at<br> central laboratory) at screening.<br><br> - Agree to have regular intercourse with current female partner with the intent of<br> spontaneous conception within 9 months from randomization.<br><br> - Agree to provide information on female partner's positive urine pregnancy test(s)<br> and documentation of ultrasound(s), delivery, and neonatal/infant health.<br><br>Current partner fulfilling the criteria below:<br><br> - Pre-menopausal woman between the ages of 18 and 38 years (both inclusive) at the<br> time of randomisation of male participant.<br><br> - Regular menstrual cycles of 21-35 days.<br><br> - No history or current condition of pelvic inflammatory disease, endometriosis stage<br> II-IV by definite or empirical diagnosis, or tubal ligation.<br><br> - Agree not to obtain infertility treatment outside of this trial for 6 months from<br> randomization of male subject.<br><br>Exclusion Criteria:<br><br> - Previous FSH treatment for =4 months not leading to conception.<br><br> - Past or current use of finasteride within 3 months prior to screening.<br><br> - Any history of anatomical disorder of the pituitary gland or testes.<br><br> - Any structural abnormalities of the vas deferens (unilateral or bilateral) at<br> screening.<br><br> - Any known, clinically significant, systemic disease in addition to the trial<br> indication that might negatively impact fertility.<br><br> - Known history or presence of clinical varicocele (subclinical and Grade 1 varicocele<br> are acceptable).<br><br> - Known history of cryptorchidism, testicular torsion, or orchitis.<br><br> - Known abnormal karyotype (including Y-chromosome microdeletion).<br><br> - Current or past treatment of urogenital (kidney, bladder, testicular, or prostate)<br> cancer as well as history of chemo- or radiotherapy that can have impact on testes.<br><br> - Any known uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary<br> disorders).<br><br> - Administration of hormonal preparations, agents known to impair testicular function<br> or affect sex hormone secretion, and known or suspected teratogens within 3 months<br> prior to screening. Administration of anabolic steroids within 12 months prior to<br> screening.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method