About the Trial

ADAM is a clinical trial investigating the effect and safety of treatment with follitropin delta (a type of FSH) in men with idiopathic (or unexplained) infertility to assess the chance of improved spontaneous pregnancy in their female partner. Some previous FSH clinical studies in males with unexplained fertility showed an improvement in pregnancy rates, both spontaneously and after assisted reproductive technology (ART). However, these studies had different designs and lack precise criteria to guide FSH administration.⁴ For this reason, further research for male infertility like the ADAM trial is needed.

⁴ Santi D, Granata AR, Simoni M. FSH treatment of male idiopathic infertility improves pregnancy rate: a meta-analysis. Endocr Connect. 2015; 4: R46-58.

• You are 18-50 years old
• Your female partner is 18-38 years old
• As a couple, you have a history of infertility for 6 months to 5 years
• You have a Body Mass Index (BMI) ≤ 40 kg/m²
• You don’t have a history of drug abuse within 12 months prior to screening
• As a couple, you cannot obtain fertility treatment outside of this trial for 6 months from enrollment

This is not a complete list of trial requirements. Additional participation requirements will be shared by the trial staff upon completion of the form available on this site.

If you and your female partner agree to participate in this trial, you will be in the trial for a duration of 12 months, at most. This includes a screening period before entering the trial that can take up to 90 days, followed by 6 months of trial drug administration, and 3 months of observation. You will come to the trial site at least 8 times during the trial for procedures and assessments, and you will participate in 3 phone calls. You will self-administer the trial drug by daily injections for 6 months, followed by an observation period of 3 months with no injections. If your participation in this trial leads to pregnancy and the birth of a baby, there will be a follow-up period of 1 year during which you will need to provide general health information about your baby. However, pregnancy cannot be guaranteed as the result of your participation in the trial.

All trial-related care is provided at no charge to trial participants, including laboratory tests, clinic procedures, and trial medication. Informed consent will be obtained from anyone choosing to participate. ADAM trial participants who complete 6 months of trial treatment will be offered cryopreservation (freezing) of semen samples for future use in assisted reproductive technology (ART) and other infertility treatment, if permitted by local laws and regulations for up to 1 year. Those who complete 6 months of trial treatment without achieving pregnancy may also be offered up to $10,000 of financial reimbursement to offset the cost of qualifying infertility treatment outside the trial, initiated and submitted for reimbursement within 9 months of the end-of-treatment visit. Qualifying treatments include further infertility diagnostics, medications for the treatment of infertility, intrauterine insemination and associated procedures, and assisted reproductive technology (ART) and associated procedures.

This is a randomized, double-blind, placebo-controlled trial to assess the effect and safety of follitropin delta for treatment of men with idiopathic (or unexplained) infertility. Follitropin delta is a human recombinant follicle-stimulating hormone (rFSH) derived from a human cell line (PER.C6®). The exploration of follitropin delta in men with idiopathic infertility aims to assess the chance of spontaneous pregnancy observed in their female partners in comparison to placebo. In this research trial, you will be assigned randomly (meaning by chance, like the toss of a coin) to receive either follitropin delta (active substance) or placebo (inactive substance). Two-thirds of the participants will receive follitropin delta and the other one-third will receive placebo. This is a double-blind trial, which means that neither you or your trial doctor will know which of the trial drug groups you have been assigned to. When participating in the trial, follitropin delta or placebo will be administered as single daily subcutaneous injections for 6 months. Follitropin delta is an investigational drug, which means it has not been approved for the treatment of men with idiopathic infertility by the respective authorities, such as the United States Food and Drug Administration (FDA). Follitropin delta is, however, approved under the trade name REKOVELLE® in more than 75 countries worldwide for the indication “Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle.” The United States Food and Drug Administration (FDA) has allowed the use of this trial drug in this research trial.

There are potential risks, discomforts, and inconveniences to being in this trial that will be discussed with you during a process called informed consent. During informed consent, detailed information about the trial will be given to you. You will have time to ask questions and talk with your loved ones before enrolling in the trial. Make sure all your questions about this trial are answered to your satisfaction before you agree to participate.