Effect of Ejaculatory Abstinence on Semen Parameters in Male Factor Infertility Patients: a Randomized Controlled Study

Overview This will be a randomized controlled study to compare semen parameters following EA for more than 48 hours (routine care) or less than 24 hours from the day of the partner's oocyte retrieval among male factor infertility patients who receive IVF/ICSI.

Methods Study participation will not influence any element of IVF treatment and all participants will be receiving the standard of care at Boston IVF. For participants who meet eligibility criteria and provide informed verbal consent, baseline demographic data will be obtained from the medical record including for example: age, race, education level, height, weight, baseline semen analysis, testosterone level, follicle stimulating hormone (FSH) level. Demographic data on the female partner will include parameters such as: age, race, education level, height, weight, gravidity, parity, anti-mullerian hormone level, and day 3 FSH.

Eligible participants will have the study introduced by the medical care team. Eligible participants will be given information on study details as well as an ejaculatory calendar/survey that can be used if the participant enrolls in the study. The medical care team will inform eligible participants that participants will receive a recruitment email from the research team at BIVFresearch@bostonivf.com followed by a phone call from the research team to see if eligible participants are willing to participate. Eligible participants who meet inclusion and exclusion criteria whom do not get information regarding the study from the medical care team will also receive a recruitment email. A research member will call eligible participants to obtain verbal consent to enroll in the study. If the participant does not answer, a voicemail will be recorded followed by a second phone call the following day. The recruitment email and verbal consent will occur between the pre-IVF period and before stimulation day 4 of the IVF cycle. If a participant consents to enrollment, the investigators will make a note in the treatment plan for the partner's IVF cycle. Enrolled participants will receive a phone call from a member of the research team during stimulation day 6 to 8 to randomize the participant to EA greater than 48 hours (routine care) or EA less than 24 hours from the day of the partner's oocyte retrieval. If the participant does not answer, a voicemail will be recorded followed by a second phone call the following day.

The semen sample provided on day of oocyte retrieval will be analyzed with a basic and advanced semen panel. Any remaining samples will be discarded per routine practice. Prior to providing the semen sample, participants will turn in the completed survey/ejaculation history calendar to a member of the research team. Blank copies will be available for participants the day of oocyte retrieval if needed.

There is no clinical risk to the IVF cycle as the procedures followed are standard clinical practice. Study participation will not influence any element of the IVF treatment except for EA counseling. Currently, there is no set protocol on how EA counseling is performed. Counseling on EA varies among the medical care teams at Boston IVF as some patients may or may not receive explicit EA instructions. Patients may be counseled by the medical care team with recommendations to abstain for greater than 48 hours. All participants in the study will use ICSI to fertilize eggs and the number of sperm needed for treatment will not be compromised by ejaculatory abstinence less than 24 hours. Participants who crossover to the alternate treatment arm will continue participation in the study so that investigators can collect cycle outcome data. IVF stimulation protocols will be according to standard practice. ICSI and embryology practice will follow standard practice. Selection of embryos will be based on the current embryology laboratory selection protocols or by preimplantation genetic testing for aneuploidy (PGT-A). The number of embryos transferred will be based on the usual American Society of Reproductive Medicine guidelines. Any unused embryos will be disposed of or cryopreserved per standard clinical protocols.