In the management of male infertility, there is a need to explore alternative treatment options to the current standard approach of in vitro fertilization (IVF). Over the past 40 years, there has been a 50% reduction in sperm counts globally, and a significant decline in sperm quality. Approximately 1 in 20 men experience reduced fertility,¹ and there is evidence this problem may be growing.²

Couples facing infertility may also experience a significant impact on their mental health, relationship and activities in their daily lives.³ This means that infertility research like the ADAM trial that focuses on the male condition is important to advance treatments, and may contribute to the development of innovative fertility solutions.

¹ Ravitsky V, Kimmins S. The forgotten men: rising rates of male infertility urgently require new approaches for its prevention, diagnosis and treatment. Biol Reprod. 2019 Nov 21;101(5):872-874. doi: 10.1093/biolre/ioz161

² Oud, M.S., Smits, R.M., Smith, H.E. et al. A de novo paradigm for male infertility. Nat Commun 13, 154 (2022). https://doi.org/10.1038/s41467-021-27132-8

³ Boivin J, Vassena R, et al. Tailored support may reduce mental and relational impact of infertility on infertile patients and partners. Reprod Biomed Online. 2022 Jun;44(6):1045-1054. doi: 10.1016/ . j.rbmo.2022.01.015.

ADAM is a trial investigating the effect and safety of treatment with follitropin delta in men with Idiopathic (or unexplained) Infertility to see if it improves the chance of spontaneous pregnancy in their female partner. The trial doctors and staff can provide more information about the trial drug. This is a placebo-controlled trial, so participants will be assigned randomly (by chance like the flip of a coin) to receive the active trial drug or a placebo. Two-thirds of the participants will receive the trial drug and one-third will receive the placebo. Neither you or your trial doctor will know which of the trial drug groups you have been assigned to until the trial ends.

These are some of the main requirements for trial participation:

• 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

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 qualify and agree to participate, 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.

The ADAM research trial is sponsored (paid for) by Ferring Pharmaceuticals. For more about this trial, visit: clinicaltrials.gov.

Participation in this trial may benefit you personally by assisting you in achieving pregnancy with your female partner and by improving important characteristics of your sperm. However, such beneficial outcomes cannot be guaranteed as the result of your participation in the trial, and you should not count on them. Even if you do not benefit personally, the results may help important future research in infertility treatment. You will be provided the trial drug, trial-related procedures and tests, and trial visits at no cost.

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).

Participation in this trial is voluntary and you can choose to end your participation at any time without affecting your future ability to receive medical care or your relationship with the study doctor. If you are interested to learn more, the trial doctor and staff will provide additional details for you to consider and answer any questions you have.

The main goal of the ADAM trial is to find out whether men with idiopathic (or unexplained) infertility treated with follitropin delta have a higher chance that their partner conceives (gets pregnant) naturally. Trial participation requires that your female partner is with you at one visit to the trial site during the screening period, since she needs to consent to parts of this trial as well. Your female partner must fulfill certain criteria in order for you to qualify for this trial. This means that following her consent, your female partner will be asked to provide information about her health and undergo certain tests that are described in detail in the consent form.