Trial Outcomes & Findings for Effect of Ejaculatory Abstinence on Semen Parameters in Male Factor Infertility Patients (NCT NCT04206800)

Results Overview

total motile sperm (million sperm) is calculated from the semen analysis by calculating: volume x concentration x motility. This gives the total motile sperm value. The difference in total motile sperm was calculated from the participants baseline semen analysis (previous analysis before starting IVF treatment) to the semen analysis the day of the egg retrieval. The mean calculated can be interpreted as a decrease (change) in total motile sperm from the participants baseline semen analysis to the semen analysis the day of the egg retrieval.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Change in baseline and 1-5 months

Results posted on

2020-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Routine Care Routine care is normally having men abstain from ejaculation from 2 to 5 days prior to the scheduled oocyte retrieval date. Men in the routine care arm will abstain from ejaculation greater than 48 hours before providing a semen sample the day of the scheduled oocyte retrieval.	Ejaculatory Abstinence Less Than 24 Hours Males will ejaculate within 24 hours of the scheduled oocyte retrieval date. Ejaculatory abstinence less than 24 hours: Males will have ejaculatory abstinence less than 24 hours before providing a semen sample the day of egg retrieval
Overall Study STARTED	4	1
Overall Study COMPLETED	4	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Routine Care n=4 Participants Routine care is normally having men abstain from ejaculation from 2 to 5 days prior to the scheduled oocyte retrieval date. Men in the routine care arm will abstain from ejaculation greater than 48 hours before providing a semen sample the day of the scheduled oocyte retrieval.	Ejaculatory Abstinence Less Than 24 Hours n=1 Participants Males will ejaculate within 24 hours of the scheduled oocyte retrieval date. Ejaculatory abstinence less than 24 hours: Males will have ejaculatory abstinence less than 24 hours before providing a semen sample the day of egg retrieval	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	1 Participants n=1 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=5 Participants
Age, Continuous	36 years STANDARD_DEVIATION 2.74 • n=4 Participants	32 years STANDARD_DEVIATION 0 • n=1 Participants	35.2 years STANDARD_DEVIATION 2.93 • n=5 Participants
Sex: Female, Male Female	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	1 Participants n=1 Participants	5 Participants n=5 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	1 participants n=1 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Change in baseline and 1-5 months

total motile sperm (million sperm) is calculated from the semen analysis by calculating: volume x concentration x motility. This gives the total motile sperm value. The difference in total motile sperm was calculated from the participants baseline semen analysis (previous analysis before starting IVF treatment) to the semen analysis the day of the egg retrieval. The mean calculated can be interpreted as a decrease (change) in total motile sperm from the participants baseline semen analysis to the semen analysis the day of the egg retrieval.

Outcome measures

Outcome measures
Measure	Routine Care n=4 Participants Routine care is normally having men abstain from ejaculation from 2 to 5 days prior to the scheduled oocyte retrieval date. Men in the routine care arm will abstain from ejaculation greater than 48 hours before providing a semen sample the day of the scheduled oocyte retrieval.	Ejaculatory Abstinence Less Than 24 Hours n=1 Participants Males will ejaculate within 24 hours of the scheduled oocyte retrieval date. Ejaculatory abstinence less than 24 hours: Males will have ejaculatory abstinence less than 24 hours before providing a semen sample the day of egg retrieval
Total Motile Sperm (Million)	14.86 million sperm Standard Deviation 24.99	7.94 million sperm Standard Deviation 0

SECONDARY outcome

Timeframe: through study completion, an average of 1 year

defined as delivery \> 23 weeks gestation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 hours after insemination

Number of fertilized eggs per oocyte retrieved

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 7 days post egg retrieval

Asses the rate of embryo development

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through study completion, an average of 1 year

defined as confirmation of gestational sac on ultrasound

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through study completion, an average of 1 year

miscarriages per total number of pregnancies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through study completion, an average of 1 year

defined as confirmation of a gestational sac with at least one fetal pole with a fetal heartbeat

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through study completion, an average of 1 year

Changes in semen analysis from baseline diagnostic sample, an advanced semen analysis panel

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through study completion, an average of 1 year

number of euploid and aneuploid embryos (if preimplantation genetic testing-aneuploidy \[PGT-A\] performed)

Outcome measures

Outcome data not reported

Adverse Events

Routine Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ejaculatory Abstinence Less Than 24 Hours

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristin Rooney

Boston IVF

Phone: 781-434-6470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place