Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality

July 3, 2022 updated by: Universitas Padjadjaran

The Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality at Assisted Reproductive Technology Clinic

An observational analytic retrospective study was conduct using cross-sectional study. The subject were oocytes from in-vitro fertilization procedures using the ICSI method at the assisted reproductive technology clinic in a private hospital in Bandung for the period 2017 - 2019. Three variables were oocyte denudation time, ICSI time and embryo quality collected from samples that met the research criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study analyses the different oocyte denudation time after ICSI on all embryos generated during IVF procedures between 1 Januaryr 2017 and 31 December 2019. All oocytes arer categorised on how many hours their denudation times were and these were then assessed for their qualities.

Study Type

Observational

Enrollment (Actual)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 hours to 8 hours (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Oocytes are derived from patients enrolled in IVF

Description

Inclusion Criteria:

  • oocytes collected from in-vitro fertilisation procedures involving intracytoplasmic sperm injection

Exclusion Criteria:

  • oocytes from patients >40 years old
  • oocytes from primary infertility >5 years
  • endometriosis
  • polycystic ovarian syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3-4 hours denudation
oocytes with 3-4 hours denudation time
Procedure: intracytoplasmic sperm injection
injection of sperm into an oocyte in assisted reproductive technology
Other Names:
  • ICSI
4-5 hours denudation
oocytes with 4-5 hours denudation time
Procedure: intracytoplasmic sperm injection
injection of sperm into an oocyte in assisted reproductive technology
Other Names:
  • ICSI
5-6 hours denudation time
oocytes with 5-6 hours denudation time
Procedure: intracytoplasmic sperm injection
injection of sperm into an oocyte in assisted reproductive technology
Other Names:
  • ICSI
6-7 hours denudation time
oocytes with 6-7 hours denudation time
Procedure: intracytoplasmic sperm injection
injection of sperm into an oocyte in assisted reproductive technology
Other Names:
  • ICSI
more than 7 hours denudation time
oocytes with more than 7 hours denudation time
Procedure: intracytoplasmic sperm injection
injection of sperm into an oocyte in assisted reproductive technology
Other Names:
  • ICSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte denudation time
Time Frame: 3 hours
time measured for oocyte denudation
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Investigators

  • Principal Investigator: Dian Tjahyadi, Universitas Padjadjaran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

July 3, 2022

First Posted (ACTUAL)

July 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 3, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OBGY-202206.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymised data on oocytes and IVF procedures are only available upon reasonable written request to the authors team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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