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

Completed

• Conditions: Infertility, Female
• Interventions: Procedure: denudation time lag

• Registration Number: NCT04185623
• Lead Sponsor: Ahmed Saad

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-04
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-18
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A (immediate denudation)	denudation time lag	Oocytes were denudated immediately after oocyte retrieval and 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.
Group B ( 2hs denudation after ovum pickup)	denudation time lag	Oocytes were denudated 2 hours after retrieval and 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.

Primary Outcome Measures

Name	Time	Method
Day 5, good quality blastocyst	120 hour post ovum pickup	Assessment were done according to gardener classification

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy	6 weeks from the last normal menstrual period	Assessment was done by observation of a gestational sac at 6 wks

Trial Locations

Locations (1)

Hawaa Fertility Center; 🇪🇬 Banhā, Qalyubiya, Egypt