The Aim of the Study is to Check Whether Follicular Fluid Evaluation Using a Spectrophotometer Can Differentiate High Quality Oocytes From Low Quality Oocytes. Oocyte Quality Will be Defined Using GDF9, BMP15 and Oocyte Morphology.

January 8, 2026 updated by: Hillel Yaffe Medical Center

Oocyte Quality Assessment Using Spectrophotometer

The aim of the study is to check whether follicular fluid evaluation using a spectrophotometer can differentiate high quality oocytes from low quality oocytes. Oocyte quality will be defined using GDF9, BMP15 and oocyte morphology. The correlation between cortisol levels in women and oocyte quality parameters will be estimated.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Israel
    • Israel
      • Hadera, Israel, Israel, 3881000
        • Hille Yaffe Medical Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 20-40 years.
  • Undergoing IVF or IVF-ICSI treatment.
  • At least five follicles visualized on ultrasound at the time of oocyte retrieval
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Age >40 years.
  • Fewer than five follicles at the time of oocyte retrieval.
  • Use of donor oocytes.
  • Significant medical comorbidities affecting ovarian function.
  • Known ovarian malignancy or prior ovarian surgery significantly affecting follicular integrity.

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: follicular fluid evaluation using spectrophotometer to differentiate high low quality oocytes
Procedure: Oocyte quality assessment using spectrophotometer

On the OPU (ovum pick-up) day the following blood biochemical markers will be measured as well- Blood interleukins 1-6, cytokine, hormone profile, lipid profile, cortisol.

After collecting the oocytes- the Follicular fluid will be sent for the following tests-

  1. mid-infrared spectrometry,
  2. P, E2, testosterone, cortisol, cytokines, IL 1-6, lipids, fatty acids.
  3. BMP-15, GDF-9 and HSPG2
  4. GCMS-Gas Chromatography Mass Spectrophotometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in follicular fluid infrared spectrophotometric profiles between high-quality and low-quality oocytes.
Time Frame: 3 Years
Infrared spectrophotometric measurements of follicular fluid collected at oocyte retrieval will be obtained using attenuated total reflection Fourier-transform infrared spectroscopy (ATR-FTIR). Oocytes will be classified as high-quality or low-quality based on predefined morphological criteria and follicular fluid levels of GDF9 and BMP15 measured by ELISA. The primary outcome will be reported as differences in normalized spectral absorbance features between the two oocyte quality groups, including discrimination performance using multivariate analysis.
3 Years

Collaborators and Investigators

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

Sponsor

Hillel Yaffe Medical Center

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)

September 22, 2024

Primary Completion (Actual)

December 16, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 0069-23-HYMC

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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