Effect of Abstinence Duration on Embryo Development

January 20, 2023 updated by: Neelke De Munck, Universitair Ziekenhuis Brussel

Effect of Abstinence Duration on Embryo Development: a Prospective Sibling Oocyte Study

The aim the investigators study is to analyze the embryo development if oocytes of the participants are injected with sperm from a longer or shorter (2 hours) abstinence duration.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants undergoing an IVF treatment, are asked to respect an abstinence duration of 2-7 days. This is to obtain a sufficient number of motile sperm. A recent investigation, analyzed the quality (number and motility) of a sperm sample produced after an abstinence duration of 4 to 7 days, followed by a second sperm sample 2 hours later. The second sample (after 2 hours) was able to produce sperm cells with a higher motility. Not only has this short abstinence duration of 2 hours a positive effect on the motility, it will also reduce the sperm DNA damage, which again has a positive effect on embryo development. Because participants need gametes of high quality to obtain embryos with a high quality, the investigators want to investigate what the effect is of abstinence duration on embryo development.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Brussels, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel
        • Principal Investigator:
          • Neelke De Munck, MSc.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients planned for embryo development up to day 5
  • at least 6 mature oocytes
  • fresh ejaculates
  • ICSI
  • fresh embryo transfer or freeze all strategy
  • all stimulation protocols
  • concentration of >1x10^6 /ml sperm

Exclusion Criteria:

  • IVF
  • IVF versus ICSI patients
  • chirurgical sperm
  • acceptors of donor oocytes
  • patients with PGD
  • patients already enrolled in another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 'normal' abstinence duration
Patients follow the normal abstinence duration as asked by the physician (2-7 days). This sperm will be used to inject half of the oocytes Intervention = second sperm sample
Husbands will be asked to produce a second sperm sample in the masturbatorium
Experimental: short abstinence duration

Patients will be asked to produce a second sperm sample, 2 hours after the first. This sperm will be used to inject the other half of the oocytes.

Intervention = second sperm sample

Husbands will be asked to produce a second sperm sample in the masturbatorium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embryo development (blastocyst stage)
Time Frame: 1 year
embryo development 5/6 of the preimplantation development
1 year
Embryo development (cleavage stage)
Time Frame: 1 year
embryo development on day 3 of the preimplantation development
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization
Time Frame: 1 year
number of fertilized oocytes per number of mature oocytes
1 year
Utilization rate
Time Frame: 1 year
number of embryos used for transfer + cryopreserved for the patient
1 year
Sperm quality
Time Frame: 1 year
concentration and motility
1 year
Sperm DNA fragmentation
Time Frame: 1 year
analysis of non-viable sperm in the two samples
1 year
Clinical Pregnancies
Time Frame: 1 year
pregnancies with a fetal heart beat
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Neelke De Munck, PhD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (Actual)

October 27, 2017

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2017/271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No data available for researchers others than the ones involved in the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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