Details
about ADAM

A Research Study for
Male Infertility

Background

ADAM is a clinical study 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 study 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.

Study Participation Requirements

  • You are 18-50 years old
  • Your female partner is 18-35 years old
  • As a couple, you have a history of infertility for 12-60 months
  • You don't have a Body Mass Index >35 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 study for 9 months from enrollment

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

Commitment

If you and your female partner agree to participate in this study, you will be in the study for a duration of 12 months, at most. This includes a screening period before entering the study that can take up to 90 days, followed by 6 months of study drug administration, and 3 months of observation. You will come to the study site at least 8 times during the study for procedures and assessments, and you will participate in 3 phone calls. You will self-administer the study drug by daily injections for 6 months, followed by an observation period of 3 months with no injections. If your participation in this study 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 study.

Process

All study-related care is provided at no charge to study participants, including laboratory tests, clinic procedures, and study medication. Informed consent will be obtained from anyone choosing to participate. ADAM study participants who complete 6 months of treatment will be offered cryopreservation (freezing) of semen samples for future use in assisted reproductive technology (ART) and other fertility treatment, if permitted by local laws and regulations for up to 1 year. Those who complete 6 months of treatment without achieving pregnancy during the full 9-month study period will also be offered financial reimbursement to offset the cost of qualifying fertility treatment outside the study, initiated and submitted for reimbursement within 6 months after the end of the study. 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.

Study Details

This is a randomized, double-blind, placebo-controlled study 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 study, 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). Half of the participants will receive follitropin delta and the other half will receive placebo. This is a double-blind study, which means that neither you or your study doctor will know which of the study drug groups you have been assigned to. When participating in the study, 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 study drug in this research study.

Risks and Informed Consent

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