A Randomized Clinical Trial Comparing Embryo Euploidy Rat... | NCT07062237

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

NCT07062237

Sponsor

UConn Health

Status

Active, not recruiting

Last Update Posted

Jul 9, 2026Actual

Enrollment

187Estimated

Phase

Not Applicable

Conditions

Infertility
Male Factor Infertility

Interventions

Ultrashort abstinence
Standard abstinence

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2025Actual

Primary Completion Date

Jun 29, 2026Actual

Completion Date

Sep 2026Estimated

First Submitted Date

Jun 28, 2025

First Submission Date that Met QC Criteria

Jul 2, 2025

First Posted Date

Jul 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2026

Last Update Posted Date

Jul 9, 2026Actual

Name	Class
The Center for Advanced Reproductive Services, P.C.	OTHER

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

187Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ultrashort abstinence	Other	Ultrashort abstinence: producing a sperm sample after 1 hour of abstinence.	Ultrashort abstinence

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Euploidy rate	Rate of embryos with normal chromosomes in both groups	Within 2-4 weeks of IVF cycle

Secondary Outcomes

Measure	Description	Time Frame
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	Within 1-2 weeks of transfer
Fertilization rate

Other Outcomes

Measure	Description	Time Frame
Sperm DNA fragmentation and DNA methylation results	Compare sperm DNA fragmentation and DNA methylation results between groups	1-2 years after initial study completed

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Non-pregnant females undergoing in vitro fertilization (IVF) with preimplantation genetic testing (PGT) with male partners who can produce a sperm sample

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 6, 2026	Apr 16, 2026	Prot_000.pdf
ICF	No	No	Yes	Informed Consent Form	Apr 6, 2026	Apr 16, 2026	ICF_001.pdf

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases