Timing of COC Denudation and Embryo Quality

• Conditions: Infertility, Female
• Interventions: Other: late denudation; Other: early denudation

• Registration Number: NCT03813745
• Lead Sponsor: Acıbadem Atunizade Hospital

Brief 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.

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 Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-21
• Study First Posted: 2019-01-23
• Study Start: 2019-06-25
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-13
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
late denudation	late denudation	Denudation will be done 2 hr after oocyte retrieval
early denudation	early denudation	Cumulus-oocyte complexes will be denudated in 30 min after oocyte retrieval

Primary Outcome Measures

Name	Time	Method
Embryo utilization rate	1 week after microinjection	Embryo utilization rate is defined as the number of embryos utilized (transferred or cryopreserved) per number of 2PN zygotes.
Number of good quality cleavage embryos	3 days after microinjection	Quality of embryos will be assessed morphologically on day 3

Secondary Outcome Measures

Name	Time	Method
Cleavage rate	2 days after microinjection	Proportion of cleaved zygotes on day 2
Fertilization rate	16-18 hour after microinjection	Proportion of injected oocytes with 2PN the day after injection
Blastulation rate	1 week after microinjection	Blastocyst rate per oocyte

Trial Locations

Locations (1)

Acibadem Altunizade Hospitai; 🇹🇷 Istanbul, Turkey