A Randomized Clinical Trial Comparing Embryo Euploidy Rates Following Ultrashort Versus Standard Abstinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-42
SponsorUConn Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrashort abstinence
Other interventionUltrashort abstinence: producing a sperm sample after 1 hour of abstinence.
Standard abstinence
Other interventionStandard abstinence: producing a sperm sample after 2-5 days of abstinence.
Treatment groups
187 Participants
are divided into 2 treatment groupsGroup A: Ultrashort abstinenceExperimental treatment 1 intervention
Group B: Standard abstinenceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Euploidy rate per oocyte
Rate of embryos with normal chromosomes in both groups
Time frame
Within 2-4 weeks of IVF cycleSecondary 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 transfer2
Fertilization rate
Proportion of oocytes fertilized in each group
Time frame
Within 1 - 2 weeks of IVF cycle3
Blastulation rate
Proportion of usable blastocysts in each group
Time frame
Within 2-3 weeks of IVF cycleOther 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 completedSponsors and contacts
Click on the lead sponsor to view all of their trials.
UConn Health
Lead sponsor
The Center for Advanced Reproductive Services, P.C.
Collaborator
Source ClinicalTrials.gov