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Active, not recruitingNCT07062237Updated Jul 9, 2026

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

An interventional study of Ultrashort abstinence and Standard abstinence in Infertility and Male Factor Infertility, sponsored by UConn Health. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by UConn Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
187
Allocation
Randomized
Ages
18 Years to 42 Years
Sex
All
01

Study 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.

Read the 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 egg retrieval. The current recommendation for abstinence prior to providing this sample is 2-7 days. However, new research has shown that there may be improved IVF outcomes with a shorter period of abstinence including improved integrity of sperm DNA (called sperm DNA fragmentation), sperm parameters (such as motility and shape), embryo quality, implantation rates, pregnancy rates, and live birth rates. One small study found that shorter abstinence may even lead to a higher rate of chromosomally normal embryos.

The purpose of this research study is to determine whether using an ultrashort period of abstinence increases the rates of embryos with normal chromosomes. On the day of egg retrieval, participants will produce two semen samples. The first sample will be collected after 2-5 days of abstinence (standard abstinence). The second sample will be collected 1 hour after the first sample (ultrashort abstinence). Both of these samples will be used for IVF.

At the time of egg retrieval, participants will have their eggs randomized (like the flip of a coin) into two groups. Half of the eggs will be exposed to sperm produced after 2-5 days of abstinence (standard abstinence). The other half of the eggs will be exposed to sperm produced after 1 hour of abstinence (ultrashort abstinence). The goal is to determine the rate of embryos with normal chromosomes in each group. Other goals include looking at how many patients get pregnant after embryo transfer.

02

Conditions studied

  • Infertility
  • Male Factor Infertility

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Keywords

  • Ultrashort abstinence
  • Sibling oocyte
  • In vitro fertilization
  • Euploid embryos
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 187 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

UConn Health is the lead sponsor of 182 studies on the registry; 18 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
187 participants (estimated)

Study arms

  • Experimental
    Ultrashort abstinence

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

    Other: Ultrashort abstinence

  • Active comparator
    Standard abstinence

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

    Other: Standard abstinence

Interventions

  • OtherUltrashort abstinence

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

  • OtherStandard abstinence

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

06

What researchers measure

Primary outcomes

  1. Euploidy rate

    Rate of embryos with normal chromosomes in both groups

    Time frame: Within 2-4 weeks of IVF cycle

Secondary outcomes

  1. Pregnancy rates after transfer of euploid embryos

    Pregnancy rate after one euploid embryo (from either experimental or control group) is transferred back into the participant in a subsequent cycle

    Time frame: Within 1-2 weeks of transfer

  2. Fertilization rate

    Proportion of oocytes fertilized in each group

    Time frame: Within 1 - 2 weeks of IVF cycle

  3. Blastulation rate

    Proportion of usable blastocysts in each group

    Time frame: Within 2-3 weeks of IVF cycle

Other outcomes

  1. Sperm DNA fragmentation and DNA methylation results

    Compare sperm DNA fragmentation and DNA methylation results between groups

    Time frame: 1-2 years after initial study completed

07

Study locations

1 site
  • The Center for Advanced Reproductive Services, P.C.
    Farmington, Connecticut 06032, United States
08

References and documents

Study documents

  • Study protocol · Apr 6, 2026
  • Informed consent form · Apr 6, 2026

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07062237
Lead sponsor
UConn Health
Collaborators
The Center for Advanced Reproductive Services, P.C.
Responsible party
Lawrence Engmann (Principal Investigator, Lead Physician, Reproductive Endocrinology and Infertility, Center for Advanced Reproductive Services, UConn Health) — Principal investigator
First posted
Jul 14, 2025
Start date
Jul 27, 2025
Primary completion
Jun 29, 2026
Completion
Sep 2026 (estimated)
Last update
Jul 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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