TerminatedNot Applicable

Effect of Ejaculatory Abstinence on Semen Parameters in Male Factor Infertility Patients

Stopped: Difficulty in enrolling participants

United States5 participantsStarted 2020-01-20

Plain-language summary

The purpose of this study is to compare semen parameters with in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) when male factor infertility patients abstain from ejaculation more than 48 hours (routine care) or less than 24 hours from the day of the partner's oocyte retrieval. The investigators hypothesize that total motile sperm count will be improved with ejaculatory abstinence (EA) less than 24 hours. Information from this trial could allow investigators to optimize chances for a successful pregnancy in patients who need IVF/ICSI.

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male Age 18 - 50 years and female age \< 38 years * First IVF cycle * Abnormal semen parameters (at least 1 of the following on 2 semen analysis with at least one being in the past 12 months): a) sperm concentration \< 10 million/mL; b) unprocessed semen analysis with \< 10 million motile sperm or processed semen analysis with \< 3 million motile sperm; c) \< 2 % normal forms (strict Kruger morphology) * Female AMH \> 0.7 and/or and day 2-4 FSH \< 12 Exclusion Criteria * Donor sperm * Males with less than 200,000/mL sperm in the ejaculate * Utilization of a gestational carrier * Frozen donor egg * Female morbid obesity: BMI \> 40 * History of recurrent pregnancy loss (≥2 spontaneous abortions) * Preimplantation genetic testing - (M or SR) Monogenetic disorders or chromosomal rearrangement * The use of non-ejaculated sperm (testicular sperm extraction)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Motile Sperm (Million)

Timeframe: Change in baseline and 1-5 months

Trial details

NCT IDNCT04206800

SponsorBoston IVF

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-15

Results submitted2020-07-21

View on ClinicalTrials.gov More Infertility, Male trials