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

NCT07062237 | Recruiting

• 1 other identifier: 25-238-1
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

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 (structures that carry genetic information) during in vitro fertilization (IVF) treatment. The investigators hypothesize that a shorter period of abstinence is effective at improving rates of normal chromosomes among embryos.

Conditions

Infertility; Male Factor Infertility

Keywords

Ultrashort abstinence; Sibling oocyte; In vitro fertilization; Euploid embryos

Outcome Measures

Primary Outcomes (1)

• Euploidy rate per oocyte

  Rate of embryos with normal chromosomes in both groups

  Within 2-4 weeks of IVF cycle

Secondary Outcomes (3)

• Pregnancy rates after transfer of euploid embryos

  Within 1-2 weeks of transfer

• Fertilization rate

  Within 1 - 2 weeks of IVF cycle

• Blastulation rate

  Within 2-3 weeks of IVF cycle

Other Outcomes (1)

• Sperm DNA fragmentation and DNA methylation results

  1-2 years after initial study completed

Study Arms (2)

Ultrashort abstinence

EXPERIMENTAL

Half of participants eggs will be exposed to sperm produced after ultrashort abstinence (1 hour of abstinence).

Other: Ultrashort abstinence

Standard abstinence

ACTIVE COMPARATOR

Half of participants eggs will be exposed to sperm produced after standard abstinence (2-5 days of abstinence).

Other: Standard abstinence

Interventions

Ultrashort abstinence OTHER

Ultrashort abstinence: producing a sperm sample after 1 hour of abstinence.

Ultrashort abstinence

Standard abstinence OTHER

Standard abstinence: producing a sperm sample after 2-5 days of abstinence.

Standard abstinence

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Non-pregnant females undergoing in vitro fertilization (IVF) with preimplantation genetic testing (PGT) with male partners who can produce a sperm sample
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UConn Health: lead
• The Center for Advanced Reproductive Services, P.C.: collaborator

Study Sites (1)

The Center for Advanced Reproductive Services, P.C.

Farmington, Connecticut, 06032, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, clinical providers, investigators and outcome assessors will be blinded to outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Lead Physician, Reproductive Endocrinology and Infertility, Center for Advanced Reproductive Services

Model Details: Sibling oocyte study: Participants will have their oocytes (eggs) divided into two groups. Half of the eggs will be exposed to sperm produced after standard abstinence, and half will be exposed to sperm produced after ultrashort abstinence.

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 14, 2025
• Study Start: July 27, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2025-06

Locations

US (1)