CClinicalTrials.gg
CompletedNCT03323892Updated Sep 19, 2024

Effect of Abstinence Duration on Embryo Development

An interventional study of second masturbation in Embryo Development, sponsored by Universitair Ziekenhuis Brussel. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Embryo Development

Keywords

  • preimplantation development
  • DNA fragmentation
  • abstinence duration
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • IVF
  • IVF versus ICSI patients
  • chirurgical sperm
  • acceptors of donor oocytes
  • patients with PGD
  • patients already enrolled in another study
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

    Other: second masturbation

  • 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

    Other: second masturbation

Interventions

  • Othersecond masturbation

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

05

What researchers measure

Primary outcomes

  1. Embryo development (blastocyst stage)

    embryo development 5/6 of the preimplantation development

    Time frame: 1 year

  2. Embryo development (cleavage stage)

    embryo development on day 3 of the preimplantation development

    Time frame: 1 year

Secondary outcomes

  1. Fertilization

    number of fertilized oocytes per number of mature oocytes

    Time frame: 1 year

  2. Utilization rate

    number of embryos used for transfer + cryopreserved for the patient

    Time frame: 1 year

  3. Sperm quality

    concentration and motility

    Time frame: 1 year

  4. Sperm DNA fragmentation

    analysis of non-viable sperm in the two samples

    Time frame: 1 year

  5. Clinical Pregnancies

    pregnancies with a fetal heart beat

    Time frame: 1 year

06

Study locations

1 site
  • Universitair Ziekenhuis Brussel
    Brussels, 1090, Belgium
07

References and documents

Individual participant data

Plan to share: No — No data available for researchers others than the ones involved in the study

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03323892
Lead sponsor
Universitair Ziekenhuis Brussel
Responsible party
Neelke De Munck (Clinical Embryologist, Universitair Ziekenhuis Brussel) — Principal investigator
First posted
Oct 27, 2017
Start date
Nov 1, 2017
Primary completion
Jun 2, 2023
Completion
Dec 31, 2023
Last update
Sep 19, 2024

Study contacts

Neelke De Munck, PhD
principal investigator · Universitair Ziekenhuis Brussel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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