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NCT Number: NCT05584436

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

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.

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Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

Akdeniz University

Antalya, 07700, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Mean number of fertilized (2PN) oocytes

    Time frame: Through study completion, an average of 1 year

    Number of oocytes with two pronuclei

  3. Mean number of high-quality blastocyst

    Time frame: Through study completion, an average of 1 year

    Number of embryos with >2BB quality

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Oct 18, 2022
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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