Timing of COC Denudation and Embryo Quality

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.

Study Overview

• Status: Unknown
• Conditions: Infertility, Female
• Intervention / Treatment: Other: early denudation; Other: late denudation

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34785
    • Recruiting
    • Acibadem Altunizade Hospitai
    • Contact: Esra Uyar; Phone Number: 2164946526; Email: dresrauyar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Those infertile patients eligible for the study design who are planned to be treated with microinjection and has given written informed consent

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
early denudation; Cumulus-oocyte complexes will be denudated in 30 min after oocyte retrieval	Other: early denudation; COCs will be denudated in 30 min after oocyte retrieval
late denudation; Denudation will be done 2 hr after oocyte retrieval	Other: late denudation; COCs will be denudated 2 hr after oocyte retrieval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of good quality cleavage embryos	Quality of embryos will be assessed morphologically on day 3	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.	1 week after microinjection

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Acıbadem Atunizade Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Anticipated): June 15, 2020
• Study Completion (Anticipated): June 25, 2020

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 21, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: IVF; embryo quality; ICSI; denudation
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: COCdenudation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No