- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03323892
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
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
- Name: Neelke De Munck, PhD
- Phone Number: 0032 024776694
- Email: neelke.demunck@uzbrussel.be
Study Contact Backup
- Name: Ileana Mateizel, PhD
- Phone Number: 0032 024749119
- Email: ileana.mateizel@uzbrussel.be
Study Locations
-
-
-
Brussels, Belgium, 1090
- Recruiting
- Universitair Ziekenhuis Brussel
-
Principal Investigator:
- Neelke De Munck, MSc.
-
Contact:
- Neelke De Munck, MSc.
- Phone Number: 0032 024776694
- Email: neelke.demunck@uzbrussel.be
-
-
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.
Sponsor
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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