Status:

RECRUITING

A Randomized Clinical Trial Comparing Embryo Euploidy Rates Following Ultrashort Versus Standard Abstinence

Lead Sponsor:

UConn Health

Collaborating Sponsors:

The Center for Advanced Reproductive Services, P.C.

Conditions:

Infertility

Male Factor Infertility

Eligibility:

All Genders

18-42 years

Phase:

NA

Brief Summary

This research is being done to determine if producing sperm after an ultrashort period of abstinence (1 hour of abstinence) will be effective in improving the rates of embryos with normal chromosomes ...

Detailed Description

As part of the in vitro fertilization (IVF) process, eggs are removed from the ovaries and are inseminated (mixed) or injected with sperm. Typically, sperm samples for IVF are produced on the day of e...

Eligibility 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.

Key Trial Info

Start Date :

July 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2027

Estimated Enrollment :

187 Patients enrolled

Trial Details

Trial ID

NCT07062237

Start Date

July 1 2025

End Date

June 1 2027

Last Update

July 14 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

The Center for Advanced Reproductive Services, P.C.

Farmington, Connecticut, United States, 06032