Active, Not Recruiting

NCT Number: NCT07329998

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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Oocyte Quality Assessment Using Spectrophotometer

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hille Yaffe Medical Center

Hadera, Israel, 3881000

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Oocyte quality assessment using spectrophotometer

Procedure

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-

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hillel Yaffe Medical Center

Other Gov

Registry information

Official study title