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Effect of Abstinence Duration on Embryo Development

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03323892
Enrollment
100
Registered
2017-10-27
Start date
2017-11-01
Completion date
2023-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embryo Development

Keywords

preimplantation development, DNA fragmentation, abstinence duration

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.

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.

Interventions

OTHERsecond masturbation

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

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Embryo development (blastocyst stage)1 yearembryo development 5/6 of the preimplantation development
Embryo development (cleavage stage)1 yearembryo development on day 3 of the preimplantation development

Secondary

MeasureTime frameDescription
Sperm quality1 yearconcentration and motility
Fertilization1 yearnumber of fertilized oocytes per number of mature oocytes
Clinical Pregnancies1 yearpregnancies with a fetal heart beat
Sperm DNA fragmentation1 yearanalysis of non-viable sperm in the two samples
Utilization rate1 yearnumber of embryos used for transfer + cryopreserved for the patient

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026