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.
Oocyte Quality Assessment Using Spectrophotometer
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 22, 2024
CompletedFirst Submitted
Initial submission to the registry
November 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2025
CompletedFirst Posted
Study publicly available on registry
January 9, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedJanuary 9, 2026
January 1, 2026
1.2 years
November 16, 2025
January 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in follicular fluid infrared spectrophotometric profiles between high-quality and low-quality oocytes.
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
Study Arms (1)
follicular fluid evaluation using spectrophotometer to differentiate high low quality oocytes
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hille Yaffe Medical Center
Hadera, Israel, 3881000, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2025
First Posted
January 9, 2026
Study Start
September 22, 2024
Primary Completion
December 16, 2025
Study Completion (Estimated)
November 1, 2026
Last Updated
January 9, 2026
Record last verified: 2026-01