Outcomes of the Embryos of Different Ovarian Follicle Sizes, and the miRNA Detection in Their Blastocyst Culture

July 9, 2023 updated by: Nazli Albayrak, Acibadem University

Evaluation of the Outcomes of the Embryos Obtained From Different Follicle Sizes, and the miRNA Detection in the Spent Media of Their Blastocyst Culture

In this study, it is aimed to analyze the outcomes of embryos obtained from ovarian follicle with different sizes, and identify the microRNA expression in the spent media of the blastocysts cultures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, it is aimed to analyze the outcomes of embryos obtained from ovarian follicle with different sizes. By this way, we assume to predict which follicle is able to give the best blastocyst. After the blastocysts are obtained from the different sized follicles, blastocyst cultures are going to be studied for the up and down-regulations of microRNA, besides the correlation of embryo quality with miRNA expression in the spent media.

Study Type

Observational

Enrollment (Estimated)

55

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
      • Istanbul, Turkey, 34303
        • Recruiting
        • Acibadem University Atakent Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • NAZLI ALBAYRAK, MD
        • Principal Investigator:
          • TURGUT AYDIN, MD
        • Sub-Investigator:
          • NADIYE KOROGLU, 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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who are going to be included to the study will be the patients of infertility clinic

Description

Inclusion Criteria:

  • Female patients aged between 20-38 who are planned to have IVF treatment
  • On the day of trigger before the oocyte pick-up, patients having at least 5, and 14 at most follicles exceeding 11mm
  • Patient having BMI below 30

Exclusion Criteria:

  • PCO patients
  • Patients having endometriosis
  • Patients having male factor with severe oligoazoospermia

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women referring to infertility clinic for IVF treatment
Women who were referred to infertility clinic with complaint of not having baby go through IVF treatment, and having oocyte pick-up procedure with different sizes of ovarian follicles
Procedure: Oocyte pick-up
With the needle, transvaginally USG-guided oocyte pick-up procedure is going to be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte grading
Time Frame: after each hyper stimulation process of the patients, when the follicle sizes are large enough to pick up which is roughly 10-15 days after the hyper stimulation has started
Morphologic Oocyte grading will be analyzed right after the procedure due to different follicle sizes
after each hyper stimulation process of the patients, when the follicle sizes are large enough to pick up which is roughly 10-15 days after the hyper stimulation has started
Day-3 Embryo Grading
Time Frame: Three days after the intracytoplasminc sperm injection(ICSI) procedure
Morphologic Day-3 embryo grading will be analyzed after the procedure due to different follicle sizes
Three days after the intracytoplasminc sperm injection(ICSI) procedure
Day-5 Embryo Grading
Time Frame: 5 days after the intracytoplasminc sperm injection(ICSI) procedure
Day-5 embryo grading(Gardner classification) will be analyzed after the procedure due to different follicle sizes
5 days after the intracytoplasminc sperm injection(ICSI) procedure
beta hCG results of the transferred embryos
Time Frame: ten days after the embryo transfer
Clinical pregnancy outcomes
ten days after the embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
micro RNA expression in culture medium
Time Frame: Culture mediums of day 5 embryos will be collected to be studied, after the last embryo is obtained and all will be studied at the end of the recruitment
In the culture medium of blastocysts are going to be analyzed for microRNA levels that are expressed
Culture mediums of day 5 embryos will be collected to be studied, after the last embryo is obtained and all will be studied at the end of the recruitment

Collaborators and Investigators

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

Sponsor

Acibadem University

Investigators

  • Principal Investigator: NAZLI ALBAYRAK, MD, Acıbadem University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 20, 2023

Primary Completion (Estimated)

October 20, 2023

Study Completion (Estimated)

December 10, 2023

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

July 9, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 9, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-10/349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD is not going to be shared with other researchers. All data is going to be known only by one researcher.

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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