InfertilityNCT07062237
A Randomized Clinical Trial Comparing Embryo Euploidy Rates Following Ultrashort Versus Standard Abstinence
A study testing Ultrashort abstinence and Standard abstinence in people with Infertility and Male Factor Infertility, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years
- Conditions the study is for
- Infertility, Male Factor Infertility
- What is being tested?
- Ultrashort abstinence and Standard abstinence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Advanced Reproductive Services, P.C.
Farmington, Connecticut, 06032
About this study
Official title: A Double-Blinded Prospective Randomized Clinical Trial Comparing Euploidy Rates Among Embryos Created From Sibling Oocytes Exposed to Sperm After Ultrashort Abstinence Compared With Standard Abstinence
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.
- Conditions
- Infertility, Male Factor Infertility
- Being tested
- Ultrashort abstinence, Standard abstinence
- Keywords
- Ultrashort abstinence, Sibling oocyte, In vitro fertilization, Euploid embryos
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrashort abstinence | Experimental | Half of participants eggs will be exposed to sperm produced after ultrashort abstinence (1 hour of abstinence). Receives: 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). Receives: Other: Standard abstinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Euploidy rate
Rate of embryos with normal chromosomes in both groups
Measured: Within 2-4 weeks of IVF cycle
Secondary outcomes (3)
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
Measured: Within 1-2 weeks of transfer
Fertilization rate
Proportion of oocytes fertilized in each group
Measured: Within 1 - 2 weeks of IVF cycle
Blastulation rate
Proportion of usable blastocysts in each group
Measured: Within 2-3 weeks of IVF cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start27 Jul 2025
- Primary completion29 Jun 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Center for Advanced Reproductive Services, P.C.
- Responsible party
- Principal investigator, Lawrence Engmann, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062237
- Sponsor's protocol ID
- 25-238-1
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded Prospective Randomized Clinical Trial Comparing Euploidy Rates Among Embryos Created From Sibling Oocytes Exposed to Sperm After Ultrashort Abstinence Compared With Standard Abstinence
- ClinicalTrials.gov ID
- NCT07062237
- Acronym / sponsor ID
- 25-238-1
- Conditions
- Infertility, Male Factor Infertility
- Keywords
- Ultrashort abstinence, Sibling oocyte, In vitro fertilization, Euploid embryos
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- The Center for Advanced Reproductive Services, P.C.
- Study start
- 27 Jul 2025 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ultrashort abstinence | Experimental | Other: Ultrashort abstinenceHalf of participants eggs will be exposed to sperm produced after ultrashort abstinence (1 hour of abstinence). |
| Standard abstinence | Active comparator | Other: Standard abstinenceHalf of participants eggs will be exposed to sperm produced after standard abstinence (2-5 days of abstinence). |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrashort abstinenceUltrashort abstinence: producing a sperm sample after 1 hour of abstinence. | Other | Ultrashort abstinence |
| Standard abstinenceStandard abstinence: producing a sperm sample after 2-5 days of abstinence. | Other | Standard abstinence |
Primary outcome
Euploidy rate
Time frame: Within 2-4 weeks of IVF cycle
Rate of embryos with normal chromosomes in both groups
3 secondary outcomes
Pregnancy rates after transfer of euploid embryos
Time frame: Within 1-2 weeks of transfer
Fertilization rate
Time frame: Within 1 - 2 weeks of IVF cycle
Blastulation rate
Time frame: Within 2-3 weeks of IVF cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Related trials for Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrashort abstinence and Standard abstinence in people with Infertility and Male Factor Infertility, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Euploidy rate (time frame: Within 2-4 weeks of IVF cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.