Effect of Abstinence Duration on Embryo Development

NCT ID: NCT03323892

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Embryo Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a prospective sibling oocyte study: both study arms will be applied to the oocytes of 1 patient
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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'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

Group Type ACTIVE_COMPARATOR

second masturbation

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

second masturbation

Intervention Type OTHER

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

Interventions

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second masturbation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Neelke De Munck

Clinical Embryologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neelke De Munck, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2017/271

Identifier Type: -

Identifier Source: org_study_id

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