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NCT Number: NCT03323892

Effect of Abstinence Duration on Embryo Development

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.

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Key information

Conditions

Embryo Development

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

second masturbation

Other

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

Primary outcomes

  1. Embryo development (blastocyst stage)

    Time frame: 1 year

    embryo development 5/6 of the preimplantation development

  2. Embryo development (cleavage stage)

    Time frame: 1 year

    embryo development on day 3 of the preimplantation development

Secondary outcomes

  1. Fertilization

    Time frame: 1 year

    number of fertilized oocytes per number of mature oocytes

  2. Utilization rate

    Time frame: 1 year

    number of embryos used for transfer + cryopreserved for the patient

  3. Sperm quality

    Time frame: 1 year

    concentration and motility

  4. Sperm DNA fragmentation

    Time frame: 1 year

    analysis of non-viable sperm in the two samples

  5. Clinical Pregnancies

    Time frame: 1 year

    pregnancies with a fetal heart beat

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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