Abstinence Period for Male Infertility

Overseen By Akeem Noziere

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Significant cardiac, pulmonary, gastrointestinal, others

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

Compensation: Varies

Number of Visits: 5

Trial Summary

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

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Abstinence Period for Male Infertility is an effective treatment?

The available research shows that a short period of abstinence before procedures like intrauterine insemination is linked to higher pregnancy rates. Another study found that the abstinence period can affect fertilization outcomes in certain fertility treatments. Additionally, for men with severe infertility, adjusting the abstinence period can improve outcomes when using assisted reproductive technologies. However, the impact of abstinence on sperm quality can vary, and some studies suggest that shorter abstinence might be better for certain conditions. ^{1 2 3 4 5}

What safety data exists for abstinence periods in male infertility treatment?

The research suggests that ejaculatory abstinence can impact semen parameters and reproductive outcomes. Studies have explored its effects on pregnancy rates, fertilization outcomes in ICSI cycles, and sperm quality. However, the influence of abstinence on sperm integrity and clinical success is still debated, indicating a need for further investigation to fully understand its safety and efficacy. ^{1 2 4 5 6}

Is the treatment 'Abstinence Period for Male Infertility' a promising treatment?

Yes, the treatment of having a short abstinence period before trying to conceive seems promising. It may improve sperm movement, which can help increase the chances of pregnancy. ^{1 2 5 7 8}

What is the purpose of this trial?

The goal of this study is to learn about the impact of abstinence periods on sperm quality in healthy males 20-45 years of age with no significant comorbidities who are able to produce a semen sample via masturbation. The main question it aims to answer is: • Do shorter abstinence periods result in improved semen quality? Participants will provide semen samples for analysis following abstinence periods of 7 days, 5 days, 2 days, 1 day, and 3 hours.

Research Team

Jonathan Gal, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for healthy men aged 20-45 who can provide a semen sample and have a sperm count of at least 1 million with high DNA fragmentation. It's not for those with low sperm counts, normal DNA fragmentation, significant health issues, or no semen production.

Inclusion Criteria

I am healthy with no major health issues.

I am a man between 20 and 45 years old.

Exclusion Criteria

Normal sperm DNA fragmentation (TUNEL assay value < 20%)

I have serious health issues related to my heart, lungs, stomach, blood, or nervous system.

Total sperm count < 1 million sperm

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Sample Collection

Participants provide semen samples following abstinence periods of 7 days, 5 days, 2 days, 1 day, and 3 hours

14 days

5 visits (in-person)

Data Analysis

Analysis of semen parameters and sperm DNA fragmentation after varying abstinence periods

Concurrent with sample collection

Treatment Details

Interventions

• Abstinence

Trial Overview The study examines how different periods of sexual abstinence (7 days, 5 days, 2 days, 1 day, and 3 hours) affect the quality of semen in participants by analyzing samples provided after each interval.

Participant Groups

Group I: Healthy Volunteers Experimental Treatment 1 Intervention

Healthy males with no significant comorbidities, aged 20-45 years who are able to produce a semen sample by masturbation.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

In a study of 6919 ICSI cycles, longer ejaculatory abstinence was linked to a decrease in the formation of 2PN zygotes, which are typically associated with successful fertilization, with a 3% decrease in likelihood for each additional day of abstinence.

Conversely, the likelihood of forming 3PN zygotes increased by 14% for each additional day of abstinence, but this change did not impact overall blastulation or clinical pregnancy rates, suggesting that while abstinence affects zygote type, it does not influence the success of the ICSI procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ejaculatory abstinence period on fertilization and clinical outcomes in ICSI cycles: a retrospective analysis. Cermisoni, GC., Minetto, S., Marzanati, D., et al.[2023]

Shorter ejaculatory abstinence intervals (less than the recommended 2-7 days) have been shown to improve sperm motility and outcomes in assisted reproductive technology (ART) for men with severe infertility.

Using fresh testicular sperm instead of frozen sperm has been associated with higher live birth rates, although more rigorous studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing outcomes for men with severe infertility. Marinaro, JA.[2023]

A short abstinence period of 2 hours before collecting a second semen sample significantly improved sperm motility and morphology in severe oligoasthenoteratozoospermic (OAT) patients, compared to their first sample.

Using a second semen sample from these patients resulted in similar pregnancy rates as those seen in normozoospermic or mild OAT patients, demonstrating that this approach can enhance fertility treatment outcomes without needing cryopreservation or surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two subsequent seminal productions: A good strategy to treat very severe oligoasthenoteratozoospermic infertile couples. Ciotti, PM., Calza, N., Zuffa, S., et al.[2022]

Short-term ejaculatory abstinence (1-5 days) improves sperm chromatin maturity and integrity, which is beneficial for therapeutic fertilization, as shown in a study of 76 ejaculates from 19 healthy volunteers.

However, prolonged incubation of spermatozoa from short-term abstinence can lead to significant DNA fragmentation, suggesting that while short-term abstinence is advantageous, care must be taken to avoid using sperm after extended in vitro exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sperm Chromatin Immaturity Observed in Short Abstinence Ejaculates Affects DNA Integrity and Longevity In Vitro. Uppangala, S., Mathai, SE., Salian, SR., et al.[2018]

A study found that an ejaculatory abstinence period of 2 days or less before intrauterine insemination (IUI) resulted in the highest pregnancy rates per cycle.

Interestingly, this increased conception rate occurred even with a lower total number of motile spermatozoa being inseminated, suggesting that timing may be more critical than sperm quantity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A short period of ejaculatory abstinence before intrauterine insemination is associated with higher pregnancy rates. Marshburn, PB., Alanis, M., Matthews, ML., et al.[2010]

In a study of 22 assisted reproduction cycles, using sperm from a sample collected 1 hour after the first ejaculate resulted in higher blastocyst euploidy rates (43.6%) compared to sperm from a sample collected after several days of abstinence (27.5%).

The findings suggest that shorter ejaculatory abstinence may improve sperm quality and reduce the risk of aneuploidy in blastocysts, indicating a potential strategy to enhance outcomes in assisted reproduction, although further randomized controlled trials are needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How 1 h of abstinence improves sperm quality and increases embryo euploidy rate after PGT-A: a study on 106 sibling biopsied blastocysts. Scarselli, F., Cursio, E., Muzzì, S., et al.[2020]

A study of 818 patients found that longer ejaculatory abstinence (more than 4 days) negatively impacts sperm quality and reduces the success rates of intracytoplasmic sperm injection (ICSI) outcomes, including fertilization and pregnancy rates.

Shorter abstinence periods (especially around 1 day) were associated with better implantation rates and higher chances of pregnancy, suggesting that optimal abstinence length is crucial for improving fertility outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting the impact of ejaculatory abstinence on semen quality and intracytoplasmic sperm injection outcomes. Borges, E., Braga, DPAF., Zanetti, BF., et al.[2020]

A systematic review of 30 studies suggests that shorter ejaculatory abstinence periods may lead to improved sperm motility characteristics, despite a decline in semen volume and sperm concentration.

Current guidelines on the optimal abstinence period for semen analysis may need to be revised, as the evidence indicates that reducing the abstinence duration could enhance sperm quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting The Relationship between The Ejaculatory Abstinence Period and Semen Characteristics. Ayad, BM., Horst, GV., Plessis, SSD.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of ejaculatory abstinence period on fertilization and clinical outcomes in ICSI cycles: a retrospective analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Optimizing outcomes for men with severe infertility. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Two subsequent seminal productions: A good strategy to treat very severe oligoasthenoteratozoospermic infertile couples. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Sperm Chromatin Immaturity Observed in Short Abstinence Ejaculates Affects DNA Integrity and Longevity In Vitro. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A short period of ejaculatory abstinence before intrauterine insemination is associated with higher pregnancy rates. [2010]

6. Netherlands pubmed.ncbi.nlm.nih.gov

How 1 h of abstinence improves sperm quality and increases embryo euploidy rate after PGT-A: a study on 106 sibling biopsied blastocysts. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Revisiting the impact of ejaculatory abstinence on semen quality and intracytoplasmic sperm injection outcomes. [2020]

8. Iran pubmed.ncbi.nlm.nih.gov

Revisiting The Relationship between The Ejaculatory Abstinence Period and Semen Characteristics. [2020]