Effect of Abstinence Duration on Embryo Development

NCT03323892 | Completed

• 1 other identifier: 2017/271
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Embryo Development

Keywords

preimplantation development; DNA fragmentation; abstinence duration

Outcome Measures

Primary Outcomes (2)

• Embryo development (blastocyst stage)

  embryo development 5/6 of the preimplantation development

  1 year

• Embryo development (cleavage stage)

  embryo development on day 3 of the preimplantation development

  1 year

Secondary Outcomes (5)

• Fertilization

  1 year

• Utilization rate

  1 year

• Sperm quality

  1 year

• Sperm DNA fragmentation

  1 year

• Clinical Pregnancies

  1 year

Study Arms (2)

'normal' abstinence duration

ACTIVE COMPARATOR

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

Other: second masturbation

short abstinence duration

EXPERIMENTAL

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

Other: second masturbation

Interventions

second masturbation OTHER

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

'normal' abstinence duration; short abstinence duration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

Study Officials

• Neelke De Munck, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Embryologist

Model Details: a prospective sibling oocyte study: both study arms will be applied to the oocytes of 1 patient

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: October 27, 2017
• Study Start: November 1, 2017
• Primary Completion: June 2, 2023
• Study Completion: December 31, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)