NCT04185623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

December 1, 2019

Last Update Submit

September 18, 2022

Conditions

Keywords

denudation timing ICSI timing oocyte aging

Outcome Measures

Primary Outcomes (1)

  • Day 5, good quality blastocyst

    Assessment were done according to gardener classification

    120 hour post ovum pickup

Secondary Outcomes (1)

  • clinical pregnancy

    6 weeks from the last normal menstrual period

Study Arms (2)

Group A (immediate denudation)

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.

Procedure: denudation time lag

Group B ( 2hs denudation after ovum pickup)

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.

Procedure: denudation time lag

Interventions

The time between ovum pickup and denudation of oocyte

Group A (immediate denudation)Group B ( 2hs denudation after ovum pickup)

Eligibility Criteria

Age24 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

couples who came seeking fertility through our IVF center

You may qualify if:

  • Women 24-37 years old
  • With good ovarian reserve
  • Induction using Long agonist protocol
  • unexplained infertility

You may not qualify if:

  • severe male factor
  • Testicular samples for ICSI
  • poor ovarian reserve
  • no of oocytes collected less than 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hawaa Fertility Center

Banhā, Qalyubia Governorate, 13512, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of Obstetrics & Gynecology

Study Record Dates

First Submitted

December 1, 2019

First Posted

December 4, 2019

Study Start

June 1, 2019

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

after completion of the study

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
after 1 year for 2 months

Locations