NCT05448859

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

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

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

June 20, 2022

Last Update Submit

July 3, 2022

Conditions

Keywords

infertilityassisted reproductive technologyembryo qualityoocyte denudationintracytoplasmic sperm injection

Outcome Measures

Primary Outcomes (1)

  • Oocyte denudation time

    time measured for oocyte denudation

    3 hours

Study Arms (5)

3-4 hours denudation

oocytes with 3-4 hours denudation time

Procedure: intracytoplasmic sperm injection

4-5 hours denudation

oocytes with 4-5 hours denudation time

Procedure: intracytoplasmic sperm injection

5-6 hours denudation time

oocytes with 5-6 hours denudation time

Procedure: intracytoplasmic sperm injection

6-7 hours denudation time

oocytes with 6-7 hours denudation time

Procedure: intracytoplasmic sperm injection

more than 7 hours denudation time

oocytes with more than 7 hours denudation time

Procedure: intracytoplasmic sperm injection

Interventions

injection of sperm into an oocyte in assisted reproductive technology

Also known as: ICSI
3-4 hours denudation4-5 hours denudation5-6 hours denudation time6-7 hours denudation timemore than 7 hours denudation time

Eligibility Criteria

Age3 Hours - 8 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Oocytes are derived from patients enrolled in IVF

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Isiklar A, Mercan R, Balaban B, Alatas C, Aksoy S, Urman B. Impact of oocyte pre-incubation time on fertilization, embryo quality and pregnancy rate after intracytoplasmic sperm injection. Reprod Biomed Online. 2004 Jun;8(6):682-6. doi: 10.1016/s1472-6483(10)61649-5.

MeSH Terms

Conditions

Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Dian Tjahyadi

    Universitas Padjadjaran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

July 8, 2022

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 8, 2022

Record last verified: 2022-07