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NCT04185623 Clinical Trial

Time Lag for Oocyte Denudation: A Better Choice for ICSI Outcome?!

Infertility, Female Clinical Trial

Official title:
Time Lag for Oocyte Denudation:Is it a Better Choice for ICSI Outcome?!

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04185623
Other study ID # Hawaa-8
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date December 1, 2020

Study information
Verified date September 2022
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aiming to investigate if difference in the timing of cumulus removal post retrieval would have any critical impact on fertilization and embryonic development.

Description:

Patients under 37 year old who were treated with controlled ovarian stimulation for ICSI were randomly divided into 2 groups; Group A: Oocytes were denudated immediately after oocyte retrieval , Group B: Oocytes were denudated 2 hours after retrieval and both groups were microinjected at 4 hours from ovum pickup. Microinjection was performed on all matured oocytes only and they were cultured to blastocyst stage.The rates of maturation, fertilization, good quality blastulation, chemical pregnancy and clinical pregnancy were analysed and compared between the two groups.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 24 Years to 37 Years
Eligibility Inclusion Criteria: - Women 24-37 years old - With good ovarian reserve - Induction using Long agonist protocol - unexplained infertility Exclusion Criteria: - severe male factor - Testicular samples for ICSI - poor ovarian reserve - no of oocytes collected less than 4

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• denudation time lag
The time between ovum pickup and denudation of oocyte

Locations
Country Name City State
Egypt Hawaa Fertility Center Banha Qalyubiya

Sponsors (2)
Lead Sponsor Collaborator
Ahmed Saad Hawaa Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Day 5, good quality blastocyst Assessment were done according to gardener classification 120 hour post ovum pickup
Secondary clinical pregnancy Assessment was done by observation of a gestational sac at 6 wks 6 weeks from the last normal menstrual period
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