Effect of Ejaculatory Abstinence on Semen Parameters in Male Factor Infertility Patients

NCT04206800 | Terminated Results

• 1 other identifier: 2019P001037
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare semen parameters with in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) when male factor infertility patients abstain from ejaculation more than 48 hours (routine care) or less than 24 hours from the day of the partner's oocyte retrieval. The investigators hypothesize that total motile sperm count will be improved with ejaculatory abstinence (EA) less than 24 hours. Information from this trial could allow investigators to optimize chances for a successful pregnancy in patients who need IVF/ICSI.

Conditions

Infertility, Male

Keywords

in-vitro fertilization; total motile sperm; male infertility; ejaculatory abstinence

Outcome Measures

Primary Outcomes (1)

• Total Motile Sperm (Million)

  total motile sperm (million sperm) is calculated from the semen analysis by calculating: volume x concentration x motility. This gives the total motile sperm value. The difference in total motile sperm was calculated from the participants baseline semen analysis (previous analysis before starting IVF treatment) to the semen analysis the day of the egg retrieval. The mean calculated can be interpreted as a decrease (change) in total motile sperm from the participants baseline semen analysis to the semen analysis the day of the egg retrieval.

  Change in baseline and 1-5 months

Secondary Outcomes (8)

• Live Birth Rate

  through study completion, an average of 1 year

• Fertilization Rate

  18 hours after insemination

• Embryo Development

  up to 7 days post egg retrieval

• Clinical Pregnancy Rate

  through study completion, an average of 1 year

• Miscarriage Rate

  through study completion, an average of 1 year

Study Arms (2)

Routine care

NO INTERVENTION

Routine care is normally having men abstain from ejaculation from 2 to 5 days prior to the scheduled oocyte retrieval date. Men in the routine care arm will abstain from ejaculation greater than 48 hours before providing a semen sample the day of the scheduled oocyte retrieval.

Ejaculatory abstinence less than 24 hours

EXPERIMENTAL

Males will ejaculate within 24 hours of the scheduled oocyte retrieval date.

Diagnostic Test: Ejaculatory abstinence less than 24 hours

Interventions

Ejaculatory abstinence less than 24 hours DIAGNOSTIC_TEST

Males will have ejaculatory abstinence less than 24 hours before providing a semen sample the day of egg retrieval

Ejaculatory abstinence less than 24 hours

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male Age 18 - 50 years and female age \< 38 years
• First IVF cycle
• Abnormal semen parameters (at least 1 of the following on 2 semen analysis with at least one being in the past 12 months): a) sperm concentration \< 10 million/mL; b) unprocessed semen analysis with \< 10 million motile sperm or processed semen analysis with \< 3 million motile sperm; c) \< 2 % normal forms (strict Kruger morphology)
• Female AMH \> 0.7 and/or and day 2-4 FSH \< 12

You may not qualify if:

• Donor sperm
• Males with less than 200,000/mL sperm in the ejaculate
• Utilization of a gestational carrier
• Frozen donor egg
• Female morbid obesity: BMI \> 40
• History of recurrent pregnancy loss (≥2 spontaneous abortions)
• Preimplantation genetic testing - (M or SR) Monogenetic disorders or chromosomal rearrangement
• The use of non-ejaculated sperm (testicular sperm extraction)

Sponsors & Collaborators

• Boston IVF: lead

Study Sites (1)

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Results Point of Contact

• Title: Kristin Rooney
• Organization: Boston IVF

krooney@bostonivf.com

781-434-6470

Study Officials

• Alan Penzias, MD

  Boston IVF

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 20, 2019
• Study Start: January 20, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-09

Locations

US (1)