NCT05584436

Brief Summary

Researchers will investigate the effect of flushing according to follicle size on the success of obtaining oocytes from a single follicle. In addition, by comparing the morphological quality of embryos developed from oocytes obtained with and without flushing, the possible effects of flushing on developing embryo quality will be investigated. By evaluating only one follicle for each patient, it is planned to investigate the effectiveness of the flushing process according to individual follicle characteristics, with a study design that has not yet been included in the literature.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
852

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

June 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

October 6, 2022

Last Update Submit

July 11, 2024

Conditions

Keywords

oocyte pick upoocyte retrievalfollicle flushing

Outcome Measures

Primary Outcomes (3)

  • Mean number of mature metaphase II oocytes

    Number of oocytes that have completed meiosis 1

    Through study completion, an average of 1 year

  • Mean number of fertilized (2PN) oocytes

    Number of oocytes with two pronuclei

    Through study completion, an average of 1 year

  • Mean number of high-quality blastocyst

    Number of embryos with \>2BB quality

    Through study completion, an average of 1 year

Study Arms (2)

oocytes obtained without flushing

First accessible follicle larger than 12 mm

oocytes obtained after flushing

Oocytes obtained after a total of 6 cc flushing of follicles that oocyte cumulus complex could not be obtained after the first aspiration

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All patients between the ages of 18-43 who will undergo OPU between June 2022 and March 2023 will be included in the study.

You may qualify if:

  • Between 18-43 years old
  • Patients who will undergo ICSI procedure

You may not qualify if:

  • Patients who will undergo oocyte cryopreservation
  • Patients with "empty follicle syndrome" in a previous OPU procedure
  • Cases that OPU cannot be performed due to premature ovulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07700, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • ŞAFAK OLGAN, MD

    Akdeniz University

    PRINCIPAL INVESTIGATOR
  • ARİF C ÖZSİPAHİ, MD

    Akdeniz University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 18, 2022

Study Start

June 1, 2021

Primary Completion

July 1, 2022

Study Completion

September 1, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations