Embryo chromosomal normality after 1-hour versus 2–5 day sperm abstinence
A Double-Blinded Prospective Randomized Clinical Trial Comparing Euploidy Rates Among Embryos Created From Sibling Oocytes Exposed to Sperm After Ultrashort Abstinence Compared With Standard Abstinence
This trial will test whether using sperm collected just 1 hour after an initial sample leads to more embryos with normal chromosomes during IVF for people with male-factor infertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 187 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | All |
| Sponsor | UConn Health Academic / other |
| Locations | 1 site (Farmington, Connecticut) |
| Trial ID | NCT07062237 on ClinicalTrials.gov |
What this trial studies
This randomized, within-patient IVF protocol has partners produce two semen samples on the day of egg retrieval: a standard sample after 2–5 days of abstinence and a second sample collected one hour later. Each participant's eggs are split (sibling oocyte design) and randomized so that half are inseminated with standard-abstinence sperm and half with ultrashort-abstinence sperm. Fertilization is by standard insemination or ICSI as clinically indicated, and embryos undergo preimplantation genetic testing (PGT-A or PGT-M) to determine chromosomal normality. The primary outcome is the rate of euploid embryos per group, with the hypothesis that ultrashort abstinence will increase euploidy rates.
Who should consider this trial
Good fit: People aged 18–42 using their own eggs and sperm for IVF with PGT-A or PGT-M who produce at least ≥6 mature oocytes for ICSI or ≥8 oocytes for standard insemination and can provide fresh semen samples are eligible.
Not a fit: People using donor eggs or sperm, frozen or surgically retrieved sperm, gestational carriers, or those with cryptozoospermia are excluded and would not benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could increase the share of chromosomally normal embryos and improve IVF success rates for couples affected by male-factor infertility.
How similar studies have performed: Small prior studies and emerging data report improved sperm DNA fragmentation, sperm parameters, and some IVF outcomes with shorter abstinence, and one small study suggested higher euploidy, but randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects are nonpregnant females ≥ 18 years and ≤ 42 years of age. * Subjects obtain greater than or equal to 6 mature oocytes at the time of oocyte retrieval for ICSI or greater than or equal to 8 oocytes at the time of oocyte retrieval for standard insemination. * Subjects are utilizing standard insemination or ICSI for fertilization. * Subjects are undergoing PGT-A (PGT for aneuploidy) or PGT-M (PGT for monogenic disorders). * Subjects are willing to comply with study protocol and procedures and provide written informed consent. Exclusion Criteria: * Subjects are utilizing donor oocytes, donor sperm, or gestational carrier. * Subjects have a diagnosis of cryptozoospermia (no spermatozoa identified in fresh semen sample). * Subjects are utilizing surgically removed sperm (e.g. via testicular sperm aspiration \[TESA\] or microsurgical epididymal sperm aspiration \[MESA\]). * Subjects are utilizing frozen/thawed sperm, including in cases in which a fresh sample was planned and the sample is insufficient for use. * Subjects are utilizing frozen/thawed oocytes. * Subjects undergoing PGT-SR (PGT for structural rearrangements). * Subjects are undergoing a day 3 (cleavage stage) embryo transfer. * Subjects obtain less than 6 mature oocytes at the time of oocyte retrieval for ICSI or less than 8 oocytes at the time of oocyte retrieval for standard insemination. * Subjects obtain greater than or equal to 6 mature oocytes at the time of oocyte retrieval for ICSI or greater than or equal to 8 oocytes at the time of oocyte retrieval for standard insemination but choose to fertilize fewer than 6 (for ICSI) or 8 (for standard insemination). * Male partner is unable to produce a second semen sample within three hours of the first semen sample (standard abstinence sample) * Male partner has an infectious disease.
Where this trial is running
Farmington, Connecticut
- The Center for Advanced Reproductive Services, P.C. — Farmington, Connecticut, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.