Effect of Abstinence Duration on Embryo Development

Embryo Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03323892
• Other study ID #: 2017/271
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Neelke De Munck, PhD
• Phone: 024776694
• Email: neelke.demunck[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embryo Development

Intervention

Other:
• second masturbation
Husbands will be asked to produce a second sperm sample in the masturbatorium

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryo development (blastocyst stage)	embryo development 5/6 of the preimplantation development	1 year
Primary	Embryo development (cleavage stage)	embryo development on day 3 of the preimplantation development	1 year
Secondary	Fertilization	number of fertilized oocytes per number of mature oocytes	1 year
Secondary	Utilization rate	number of embryos used for transfer + cryopreserved for the patient	1 year
Secondary	Sperm quality	concentration and motility	1 year
Secondary	Sperm DNA fragmentation	analysis of non-viable sperm in the two samples	1 year
Secondary	Clinical Pregnancies	pregnancies with a fetal heart beat	1 year