Effect of Abstinence Duration on Embryo Development

Study Overview
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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.

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

Conditions
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Embryo Development

Intervention / Treatment
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* Other: second masturbation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a prospective sibling oocyte study: both study arms will be applied to the oocytes of 1 patient
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 'normal' abstinence duration<br>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<br>* Husbands will be asked to produce a second sperm sample in the masturbatorium<br>|
| Experimental: short abstinence duration<br>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<br>* Husbands will be asked to produce a second sperm sample in the masturbatorium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preimplantation development, DNA fragmentation, abstinence duration