Embryo DevelopmentNCT03323892
Effect of Abstinence Duration on Embryo Development
A study testing second masturbation in people with Embryo Development, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Embryo Development
- What is being tested?
- second masturbation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2017to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- IVF
- IVF versus ICSI patients
- chirurgical sperm
- acceptors of donor oocytes
- patients with PGD
- patients already enrolled in another study
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, 1090
About this study
Official title: 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.
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.
- Conditions
- Embryo Development
- Being tested
- second masturbation
- Keywords
- preimplantation development, DNA fragmentation, abstinence duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
second masturbationOther
Husbands will be asked to produce a second sperm sample in the masturbatorium
| Study group | Role | What they receive |
|---|---|---|
| 'normal' abstinence duration | Active comparator | 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 Receives: Other: second masturbation |
| short abstinence duration | Experimental | 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 Receives: Other: second masturbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo development (blastocyst stage)
embryo development 5/6 of the preimplantation development
Measured: 1 year
Embryo development (cleavage stage)
embryo development on day 3 of the preimplantation development
Measured: 1 year
Secondary outcomes (5)
Fertilization
number of fertilized oocytes per number of mature oocytes
Measured: 1 year
Utilization rate
number of embryos used for transfer + cryopreserved for the patient
Measured: 1 year
Sperm quality
concentration and motility
Measured: 1 year
Sperm DNA fragmentation
analysis of non-viable sperm in the two samples
Measured: 1 year
Clinical Pregnancies
pregnancies with a fetal heart beat
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Nov 2017
- Primary completion2 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective sibling oocyte study: both study arms will be applied to the oocytes of 1 patient
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neelke De Munck, Universitair Ziekenhuis Brussel
- Investigators
- Neelke De Munck, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323892
- Sponsor's protocol ID
- 2017/271
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data available for researchers others than the ones involved in the study
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abstinence Duration on Embryo Development: a Prospective Sibling Oocyte Study
- ClinicalTrials.gov ID
- NCT03323892
- Acronym / sponsor ID
- 2017/271
- Conditions
- Embryo Development
- Keywords
- preimplantation development, DNA fragmentation, abstinence duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a prospective sibling oocyte study: both study arms will be applied to the oocytes of 1 patient
| Arm | Type | Receives |
|---|---|---|
| 'normal' abstinence duration | Active comparator | Other: second masturbationPatients 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 |
| short abstinence duration | Experimental | Other: second masturbationPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients planned for embryo development up to day 5
- at least 6 mature oocytes
- fresh ejaculates
- ICSI
- fresh embryo transfer or freeze all strategy
Key exclusion criteria (6 listed)
- IVF
- IVF versus ICSI patients
- chirurgical sperm
- acceptors of donor oocytes
- patients with PGD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| second masturbationHusbands will be asked to produce a second sperm sample in the masturbatorium | Other | 'normal' abstinence duration, short abstinence duration |
Primary outcome
Embryo development (blastocyst stage)
Time frame: 1 year
embryo development 5/6 of the preimplantation development
Embryo development (cleavage stage)
Time frame: 1 year
embryo development on day 3 of the preimplantation development
5 secondary outcomes
Fertilization
Time frame: 1 year
Utilization rate
Time frame: 1 year
Sperm quality
Time frame: 1 year
Sperm DNA fragmentation
Time frame: 1 year
Clinical Pregnancies
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. No data available for researchers others than the ones involved in the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neelke De Munck, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing second masturbation in people with Embryo Development, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryo development (blastocyst stage) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.