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

UConn Health187 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Conditions

Infertility Male Factor Infertility

Interventions

Ultrashort abstinenceOTHER

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

Standard abstinenceOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 42 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Center for Advanced Reproductive Services, P.C.

Farmington, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

Euploidy rate per oocyte

Rate of embryos with normal chromosomes in both groups

Time frame: Within 2-4 weeks of IVF cycle

Secondary Outcomes

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

Fertilization rate

Proportion of oocytes fertilized in each group

Time frame: Within 1 - 2 weeks of IVF cycle

Blastulation rate

Proportion of usable blastocysts in each group

Time frame: Within 2-3 weeks of IVF cycle

Data from ClinicalTrials.gov

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