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NCT03813745 Clinical Trial

Timing of COC Denudation and Embryo Quality

Infertility, Female Clinical Trial

Official title:
Timing of COC Denudation and Embryo Quality: A Prospective Randomised Sibling-Oocyte Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03813745
Other study ID # COCdenudation
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 25, 2019
Est. completion date June 25, 2020

Study information
Verified date January 2019
Source Acibadem Atunizade Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 25, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- COH with GnRH antagonist cycle

- 5 or more oocytes collected

Exclusion Criteria:

- 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).

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• early denudation
COCs will be denudated in 30 min after oocyte retrieval
• late denudation
COCs will be denudated 2 hr after oocyte retrieval

Locations
Country Name City State
Turkey Acibadem Altunizade Hospitai Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Acibadem Atunizade Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of good quality cleavage embryos Quality of embryos will be assessed morphologically on day 3 3 days after microinjection
Primary Embryo utilization rate Embryo utilization rate is defined as the number of embryos utilized (transferred or cryopreserved) per number of 2PN zygotes. 1 week after microinjection
Secondary Fertilization rate Proportion of injected oocytes with 2PN the day after injection 16-18 hour after microinjection
Secondary Cleavage rate Proportion of cleaved zygotes on day 2 2 days after microinjection
Secondary Blastulation rate Blastocyst rate per oocyte 1 week after microinjection
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