NCT03813745

Brief Summary

The relation between the timing of COC denudation and oocyte /embryo quality is controversial. The aim of this study is to examine whether timing of denudation of sibling oocytes has any effect on embryo quality.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

June 25, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
Last Updated

December 13, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

January 10, 2019

Last Update Submit

December 12, 2019

Conditions

Infertility, Female

Keywords

embryo qualitydenudationIVFICSI

Outcome Measures

Primary Outcomes (2)

  • Number of good quality cleavage embryos

    Quality of embryos will be assessed morphologically on day 3

    3 days after microinjection

  • Embryo utilization rate

    Embryo utilization rate is defined as the number of embryos utilized (transferred or cryopreserved) per number of 2PN zygotes.

    1 week after microinjection

Secondary Outcomes (3)

  • Fertilization rate

    16-18 hour after microinjection

  • Cleavage rate

    2 days after microinjection

  • Blastulation rate

    1 week after microinjection

Study Arms (2)

early denudation

Cumulus-oocyte complexes will be denudated in 30 min after oocyte retrieval

Other: early denudation

late denudation

Denudation will be done 2 hr after oocyte retrieval

Other: late denudation

Interventions

early denudationOTHER

COCs will be denudated in 30 min after oocyte retrieval

early denudation
late denudationOTHER

COCs will be denudated 2 hr after oocyte retrieval

late denudation

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Those infertile patients eligible for the study design who are planned to be treated with microinjection and has given written informed consent

You may qualify if:

  • COH with GnRH antagonist cycle
  • or more oocytes collected

You may not qualify if:

  • Fewer than 4 oocytes after retrieval
  • Previous history of total fertilization failure or oocyte maturation arrest
  • Male partner requiring surgical sperm retrieval (MESA or TESA).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Altunizade Hospitai

Istanbul, 34785, Turkey (Türkiye)

RECRUITING

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
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 23, 2019

Study Start

June 25, 2019

Primary Completion

June 15, 2020

Study Completion

June 25, 2020

Last Updated

December 13, 2019

Record last verified: 2019-01

Locations

TU(1)