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Completed

NCT Number: NCT04185623

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

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

24 year–37 year

Sex eligibility

Female

Study type

Observational

Primary location

Hawaa Fertility Center

Banhā, Qalyubia Governorate, 13512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

denudation time lag

Procedure

The time between ovum pickup and denudation of oocyte

Primary outcomes

  1. Day 5, good quality blastocyst

    Time frame: 120 hour post ovum pickup

    Assessment were done according to gardener classification

Secondary outcomes

  1. clinical pregnancy

    Time frame: 6 weeks from the last normal menstrual period

    Assessment was done by observation of a gestational sac at 6 wks

Sponsors and collaborators

Lead sponsor

Ahmed Saad

Other

Collaborators

  • Hawaa Fertility Center

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2019
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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