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

NCT ID: NCT05584436

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 852 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-09-01

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.

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.

Conditions

Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

oocytes obtained without flushing

First accessible follicle larger than 12 mm

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

ŞAFAK OLGAN

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ŞAFAK OLGAN, MD

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

ARİF C ÖZSİPAHİ, MD

Role: STUDY_CHAIR

Akdeniz University

Locations

Akdeniz University

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

49829697

Identifier Type: -

Identifier Source: org_study_id