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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04206800
Recruitment Status : Terminated (Difficulty in enrolling participants)
First Posted : December 20, 2019
Results First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Boston IVF

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.

Condition or disease Intervention/treatment Phase
Infertility, Male Diagnostic Test: Ejaculatory abstinence less than 24 hours Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Ejaculatory Abstinence on Semen Parameters in Male Factor Infertility Patients: a Randomized Controlled Study
Actual Study Start Date : January 20, 2020
Actual Primary Completion Date : July 15, 2020
Actual Study Completion Date : July 15, 2020


Arm Intervention/treatment
No Intervention: Routine care
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.
Experimental: Ejaculatory abstinence less than 24 hours
Males will ejaculate within 24 hours of the scheduled oocyte retrieval date.
Diagnostic Test: Ejaculatory abstinence less than 24 hours
Males will have ejaculatory abstinence less than 24 hours before providing a semen sample the day of egg retrieval




Primary Outcome Measures :
  1. Total Motile Sperm (Million) [ Time Frame: Change in baseline and 1-5 months ]
    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.


Secondary Outcome Measures :
  1. Live Birth Rate [ Time Frame: through study completion, an average of 1 year ]
    defined as delivery > 23 weeks gestation

  2. Fertilization Rate [ Time Frame: 18 hours after insemination ]
    Number of fertilized eggs per oocyte retrieved

  3. Embryo Development [ Time Frame: up to 7 days post egg retrieval ]
    Asses the rate of embryo development

  4. Clinical Pregnancy Rate [ Time Frame: through study completion, an average of 1 year ]
    defined as confirmation of gestational sac on ultrasound

  5. Miscarriage Rate [ Time Frame: through study completion, an average of 1 year ]
    miscarriages per total number of pregnancies

  6. Ongoing Pregnancy Rate [ Time Frame: through study completion, an average of 1 year ]
    defined as confirmation of a gestational sac with at least one fetal pole with a fetal heartbeat

  7. Semen Analysis [ Time Frame: through study completion, an average of 1 year ]
    Changes in semen analysis from baseline diagnostic sample, an advanced semen analysis panel

  8. Preimplantation Genetic Testing [ Time Frame: through study completion, an average of 1 year ]
    number of euploid and aneuploid embryos (if preimplantation genetic testing-aneuploidy [PGT-A] performed)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206800


Locations
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United States, Massachusetts
Boston IVF
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Boston IVF
Investigators
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Principal Investigator: Alan Penzias, MD Boston IVF
  Study Documents (Full-Text)

Documents provided by Boston IVF:
Informed Consent Form  [PDF] December 11, 2019

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Responsible Party: Boston IVF
ClinicalTrials.gov Identifier: NCT04206800    
Other Study ID Numbers: 2019P001037
First Posted: December 20, 2019    Key Record Dates
Results First Posted: September 25, 2020
Last Update Posted: September 25, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston IVF:
in-vitro fertilization
total motile sperm
male infertility
ejaculatory abstinence
Additional relevant MeSH terms:
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Infertility
Infertility, Male