Abstinence Duration for Male Infertility

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: UConn Health

Disqualifiers: Donor gametes, Cryptozoospermia, Frozen gametes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

187 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a very short period of abstinence, just one hour, can increase the likelihood of producing embryos with normal chromosomes during IVF. Researchers will compare this ultrashort abstinence with the standard 2-5 days of abstinence to determine which is more effective. Women undergoing IVF who have retrieved a good number of eggs may be suitable candidates. The trial focuses on participants using fresh sperm samples and not using donor eggs or sperm. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve IVF success rates.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for improving embryo chromosomal normalcy in IVF?

Research has shown that shorter breaks between ejaculations can affect sperm quality. Some studies suggest that shorter intervals might improve sperm motility and reduce DNA damage, which could benefit men facing infertility issues. However, other reports indicate that very short breaks, such as four hours, might result in less semen and fewer sperm compared to longer breaks of two to seven days.

Overall, shorter breaks might enhance some aspects of sperm quality but could weaken others. Discussing this approach with a doctor is important to determine its suitability. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different durations of abstinence affect male infertility treatment outcomes. Unlike traditional methods that recommend 2-5 days of abstinence before sperm collection, the trial is investigating the effects of ultrashort abstinence, which involves only one hour of abstinence. This approach could offer quicker and potentially more efficient fertility solutions. By understanding the impact of varying abstinence periods, this research could lead to optimized protocols for male infertility, potentially improving success rates for conception.

What evidence suggests that this trial's treatments could be effective for improving embryo chromosomal normalcy in IVF?

This trial will compare the effects of ultrashort abstinence with standard abstinence on sperm quality. Research has shown that a shorter time without ejaculation can improve sperm quality. Specifically, studies found that sperm collected after just 1 hour of abstinence, as tested in the ultrashort abstinence arm of this trial, had a higher total sperm count and moved better compared to longer periods without ejaculation. Shorter abstinence times might also reduce sperm damage, potentially leading to healthier embryos. This suggests that very short abstinence could be a promising method to improve embryo quality during IVF. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals or couples dealing with infertility issues, specifically male infertility. Participants should be undergoing in vitro fertilization (IVF) treatment and willing to produce sperm after either an ultrashort period of abstinence (1 hour) or adhere to the standard abstinence guidelines.

Inclusion Criteria

Subjects are willing to comply with study protocol and procedures and provide written informed consent

I am a woman aged 18 to 42 and not pregnant.

I can produce 6+ oocytes for ICSI or 8+ for standard insemination.

Exclusion Criteria

Subjects utilizing donor oocytes, donor sperm, or gestational carrier

Subjects utilizing frozen/thawed sperm

Subjects utilizing frozen/thawed oocytes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

IVF Treatment

Participants undergo IVF treatment with eggs exposed to sperm after ultrashort and standard abstinence periods

2-4 weeks

Multiple visits for egg retrieval and sperm sample collection

Embryo Transfer

Transfer of euploid embryos back into participants

1-2 weeks

1 visit for embryo transfer

Follow-up

Participants are monitored for pregnancy rates and embryo development outcomes

1-2 weeks

Follow-up visits for pregnancy testing

Long-term Follow-up

Assessment of sperm DNA fragmentation and DNA methylation results

1-2 years

What Are the Treatments Tested in This Trial?

Interventions

• Standard abstinence
• Ultrashort abstinence

Trial Overview The study aims to compare embryo health, particularly the normalcy of chromosomes, between two groups: one following a very brief abstinence period before producing sperm (1 hour), and another adhering to standard abstinence practices prior to IVF.

How Is the Trial Designed?

Group I: Ultrashort abstinence Experimental Treatment 1 Intervention

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

Group II: Standard abstinence Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

The Center for Advanced Reproductive Services, P.C.

Collaborator

Trials

1

Recruited

150+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6708030/

How 1 h of abstinence improves sperm quality and ... Most of the studies detected an increase in total sperm count and in progressive spermatozoa rate, in ejaculates with a shorter abstinence ...

2. fertstert.org fertstert.org/article/S0015-0282(23)01998-2/fulltext

We are giving the wrong patient instructions for semen ... Providing a semen sample with as little as 1–4 hours of abstinence may provide sperm with even less damage. A short abstinence (<24 hours) ...

3. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1373426/full

Effects of long and short ejaculatory abstinence on sperm ... Short ejaculatory abstinence is associated with better sperm quality. Indeed, a higher percentage of progressive sperm motility and lower levels of SDF have ...

4. urotoday.com urotoday.com/recent-abstracts/men-s-health/male-infertility/63736-twenty-four-hours-abstinence-and-the-quality-of-sperm-parameters-abstract.html?page=1

Twenty-four hours abstinence and the quality of sperm ... In those with normal basic semen parameters, a reduction in semen quality is expected after 24 h, and a single-timed insemination and longer ...

5. ecerm.org ecerm.org/m/journal/view.php?number=1302

Effects of a short abstinence period on sperm quality ... The semen volume, concentration, and total sperm count were significantly decreased after 4 hours of abstinence than after 2 to 7 days of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38197853/

a systematic review and dose-response meta-analysis Short-term abstinence may be associated with limited improvements in semen quality in healthy men but could be more beneficial for infertile men.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10711244/

Effects of a short abstinence period on sperm quality in ... Results. The semen volume, concentration, and total sperm count were significantly decreased after 4 hours of abstinence than after 2 to 7 days ...

8. wjmh.org wjmh.org/DOIx.php?id=10.5534/wjmh.240035

Impact of Shorter Abstinence Periods on Semen Parameters In conclusion, our findings suggest a shorter abstinence period could be beneficial due to its effect on sperm motility and DNA fragmentation.