A Research Study for Male Infertility
How can you participate in this study?
Fill out the short form on this website
Someone will contact you with more information and to check that you meet all eligibility requirements
Sign the informed consent
Go through the screening process
Enroll in the study
Begin study participation
How can you benefit from study participation?
Increased Chance of Achieving Spontaneous Pregnancy
ADAM study participants might benefit in the form of an improvement in their sperm quality and by achieving pregnancy of their female partners. If you choose to participate in the study, the cost of the study drug, study-related procedures and tests will be paid for by the study sponsor.
Extended Fertility Support for Completing Study Requirements
ADAM study participants who complete 6 months of study treatment will be offered cryopreservation (freezing) of semen samples for future use in assisted reproductive technology (ART) and other fertility treatment.* 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.**
*If permitted by local laws and regulations for up to 1 year
**Initiated and submitted for reimbursement within 6 months after the end of the study
Where can you find us?
This research study is actively seeking participants at these locations throughout the United States:
Why is this study happening?
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 study that focus on the male condition is essential 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 10.1093/biolre/ioz161
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.
What medication will I be taking?
ADAM is a study 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 study doctors and staff can provide more information about the study drug. This is a placebo-controlled study, so participants will be assigned randomly (by chance like the flip of a coin) to receive the active study drug or a placebo. Half of the participants will receive one and the other half will receive the other. Neither you or your study doctor will know which of the study drug groups you have been assigned to until the study ends.
How do I know if I'm eligible?
These are some of the main requirements for study participation:
- 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 do not have a Body Mass Index >35 kg/m2
- You do not have a history of drug abuse within 12 months prior to screening
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.
What does study participation look like?
If you and your female partner qualify and agree to participate, 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.
Who is conducting this research study?
The ADAM research study is sponsored (paid for) by Ferring Pharmaceuticals.
Why should I participate?
Participation in this study 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 study, 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 study drug, study-related procedures and tests, and study visits at no cost.
If you complete 6 months of study treatment, you will be offered the freezing of sperm samples for future use in fertility treatment, provided that your local regulations permit this. Those who complete 6 months of study treatment and do not achieve 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.
Participation in this study is voluntary and you can choose to participate, or leave it, at any time. If you are interested to learn more, the study doctor and staff will provide additional details for you to consider and answer any questions you have.
What is the role of female partners in this research study?
The main goal of the ADAM study 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. Study participation requires that your female partner is with you at one visit to the study site during the screening period, since she needs to consent to parts of this study as well. Your female partner must fulfill certain criteria in order for you to qualify for this study. 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.