Effect of Abstinence Duration on Embryo Development

Not Applicable

Recruiting

• Conditions: Embryo Development
• Interventions: Other: second masturbation

• Registration Number: NCT03323892
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-27
• Study Start: 2017-11-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short abstinence duration	second masturbation	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
'normal' abstinence duration	second masturbation	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

Primary Outcome Measures

Name	Time	Method
Embryo development (blastocyst stage)	1 year	embryo development 5/6 of the preimplantation development
Embryo development (cleavage stage)	1 year	embryo development on day 3 of the preimplantation development

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium