Timing of COC Denudation and Embryo Quality

• Sponsor: Acıbadem Atunizade Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03813745
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Timing of COC Denudation and Embryo Quality: A Prospective Randomised Sibling-Oocyte Study
• Actual Study Start Date: Jun 25, 2019
• Anticipated Primary Completion Date: Jun 15, 2020
• Anticipated Study Completion Date: Jun 25, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Number of good quality cleavage embryos [3 days after microinjection]

   Quality of embryos will be assessed morphologically on day 3

2. 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.

Secondary Outcome Measures

1. Fertilization rate [16-18 hour after microinjection]

   Proportion of injected oocytes with 2PN the day after injection

2. Cleavage rate [2 days after microinjection]

   Proportion of cleaved zygotes on day 2

3. Blastulation rate [1 week after microinjection]

   Blastocyst rate per oocyte

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acibadem Altunizade Hospitai	Istanbul		Turkey	34785

Sponsors and Collaborators

• Acıbadem Atunizade Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elif Esra Uyar, Medical Doctor, Acıbadem Atunizade Hospital
• ClinicalTrials.gov Identifier: NCT03813745
• Other Study ID Numbers: COCdenudation
• First Posted: Jan 23, 2019
• Last Update Posted: Dec 13, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elif Esra Uyar, Medical Doctor, Acıbadem Atunizade Hospital: embryo quality; denudation; IVF; ICSI
• Additional relevant MeSH terms: Infertility; Infertility, Female

Study Results

No Results Posted as of Dec 13, 2019