The Effect of Follicular Flushing on Oocyte Retrieval Rate and Embryo Quality

May 20, 2023 updated by: ŞAFAK OLGAN, Akdeniz University

The Effect of Follicular Flushing on Oocyte Retrieval Rate and Quality of Embryo Developing From the Index Oocyte: Prospective Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Prior to the oocyte pick up (OPU) procedure, the dimensions (height x width x depth) of the first accessible follicle in any ovary will be recorded in millimeters. In this regard, any follicle larger than 12 mm will be selected for the first aspiration. It is planned to evaluate the effectiveness of the washing process in follicles with different sizes by performing the first aspiration procedure regardless of the follicle size. After aspiration of all the follicle fluid with a double lumen needle (17 Gauge), the remaining fluid in the needle and line will be aspirated by giving 2 cc "flushing medium" to the follicle. In this way, all of the pure follicle fluid will be delivered to the in vitro fertilization (IVF) laboratory with the OPU tube for initial evaluation. After the evaluation, if no cumulus oocyte complex (COC) is observed in the first sample, the washing process will be started. In this regard, flushing and aspiration will be performed respectively by giving 2 cc "flushing medium" to the same follicle 3 times. A total of 6 cc flushing medium obtained after the flushing-aspiration process will be delivered to the IVF laboratory and the presence of COC in it will be investigated again under the microscope. Depending on the retrieval of oocyte by direct aspiration or flushing, each oocyte will be followed individually and its quality will be evaluated in case of embryo development from this oocyte.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Antalya, Turkey, 07700
        • Recruiting
        • Akdeniz University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Şafak Olgan, MD
        • Sub-Investigator:
          • Arif C Özsipahi, MD

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

18 years to 43 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean number of mature metaphase II oocytes
Time Frame: Through study completion, an average of 1 year
Number of oocytes that have completed meiosis 1
Through study completion, an average of 1 year
Mean number of fertilized (2PN) oocytes
Time Frame: Through study completion, an average of 1 year
Number of oocytes with two pronuclei
Through study completion, an average of 1 year
Mean number of high-quality blastocyst
Time Frame: Through study completion, an average of 1 year
Number of embryos with >2BB quality
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: ŞAFAK OLGAN, MD, Akdeniz University
  • Study Chair: ARİF C ÖZSİPAHİ, MD, Akdeniz University

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)

June 1, 2022

Primary Completion (Anticipated)

July 15, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 15, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 20, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49829697

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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