Infertility, FemaleNCT03813745
Timing of COC Denudation and Embryo Quality
An observational study of Infertility, Female, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
Trial summary
The relation between the timing of COC denudation and oocyte /embryo quality is controversial. The aim of this study is to examine whether timing of denudation of sibling oocytes has any effect on embryo quality. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- early denudation and late denudation
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2019to 25 Jun 2020
- Phase
- Observational
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Those infertile patients eligible for the study design who are planned to be treated with microinjection and has given written informed consent
Who may be able to join
- COH with GnRH antagonist cycle
- 5 or more oocytes collected
Who cannot join
- Fewer than 4 oocytes after retrieval
- Previous history of total fertilization failure or oocyte maturation arrest
- Male partner requiring surgical sperm retrieval (MESA or TESA).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Altunizade Hospitai
Istanbul, 34785
Esra Uyar, 2164946526, dresrauyar@gmail.com
About this study
Official title: Timing of COC Denudation and Embryo Quality: A Prospective Randomised Sibling-Oocyte Study
The relation between the timing of COC denudation and oocyte /embryo quality is controversial. The aim of this study is to examine whether timing of denudation of sibling oocytes has any effect on embryo quality.
Read the detailed description
Retrieved sibling cumulus-oocyte complexes (COCs) will be randomly divided into two groups, in the first group denudation will be in 30 minutes after oocyte retrieval, in second group denudation will take place after 2 hours of incubation.
- Conditions
- Infertility, Female
- Being tested
- early denudation, late denudation
- Keywords
- embryo quality, denudation, IVF, ICSI
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early denudationOther
COCs will be denudated in 30 min after oocyte retrieval
late denudationOther
COCs will be denudated 2 hr after oocyte retrieval
| Study group | Role | What they receive |
|---|---|---|
| early denudation | Cumulus-oocyte complexes will be denudated in 30 min after oocyte retrieval Receives: Other: early denudation | |
| late denudation | Denudation will be done 2 hr after oocyte retrieval Receives: Other: late denudation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of good quality cleavage embryos
Quality of embryos will be assessed morphologically on day 3
Measured: 3 days after microinjection
Embryo utilization rate
Embryo utilization rate is defined as the number of embryos utilized (transferred or cryopreserved) per number of 2PN zygotes.
Measured: 1 week after microinjection
Secondary outcomes (3)
Fertilization rate
Proportion of injected oocytes with 2PN the day after injection
Measured: 16-18 hour after microinjection
Cleavage rate
Proportion of cleaved zygotes on day 2
Measured: 2 days after microinjection
Blastulation rate
Blastocyst rate per oocyte
Measured: 1 week after microinjection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start25 Jun 2019
- Primary completion15 Jun 2020 (estimated)
- Study completion25 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Esra Uyar, Acıbadem Atunizade Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813745
- Sponsor's protocol ID
- COCdenudation
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of COC Denudation and Embryo Quality: A Prospective Randomised Sibling-Oocyte Study
- ClinicalTrials.gov ID
- NCT03813745
- Acronym / sponsor ID
- COCdenudation
- Conditions
- Infertility, Female
- Keywords
- embryo quality, denudation, IVF, ICSI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 25 Jun 2020 (estimated)
- First posted
- 23 Jan 2019 (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 relation between the timing of COC denudation and oocyte /embryo quality is controversial. The aim of this study is to examine whether timing of denudation of sibling oocytes has any effect on embryo quality.
Detailed description
Retrieved sibling cumulus-oocyte complexes (COCs) will be randomly divided into two groups, in the first group denudation will be in 30 minutes after oocyte retrieval, in second group denudation will take place after 2 hours of incubation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early denudation | – | Other: early denudationCumulus-oocyte complexes will be denudated in 30 min after oocyte retrieval |
| late denudation | – | Other: late denudationDenudation will be done 2 hr after oocyte retrieval |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Those infertile patients eligible for the study design who are planned to be treated with microinjection and has given written informed consent
Key inclusion criteria (2 listed)
- COH with GnRH antagonist cycle
- 5 or more oocytes collected
Key exclusion criteria (3 listed)
- Fewer than 4 oocytes after retrieval
- Previous history of total fertilization failure or oocyte maturation arrest
- Male partner requiring surgical sperm retrieval (MESA or TESA).
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 |
|---|---|---|
| early denudationCOCs will be denudated in 30 min after oocyte retrieval | Other | early denudation |
| late denudationCOCs will be denudated 2 hr after oocyte retrieval | Other | late denudation |
Primary outcome
Number of good quality cleavage embryos
Time frame: 3 days after microinjection
Quality of embryos will be assessed morphologically on day 3
Embryo utilization rate
Time frame: 1 week after microinjection
Embryo utilization rate is defined as the number of embryos utilized (transferred or cryopreserved) per number of 2PN zygotes.
3 secondary outcomes
Fertilization rate
Time frame: 16-18 hour after microinjection
Cleavage rate
Time frame: 2 days after microinjection
Blastulation rate
Time frame: 1 week after microinjection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Dec 2019. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of good quality cleavage embryos (time frame: 3 days after microinjection). 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 13 Dec 2019.