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.

NCT07329998 — Not applicable, Active not recruiting, 200 participants, Hillel Yaffe Medical Center

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Oocyte Quality Assessment Using Spectrophotometer

RegistryNCT07329998
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, screening
Enrollment200 (Estimated)
SponsorHillel Yaffe Medical Center (Other gov)
ConditionsOocyte Quality Assessment Using Spectrophotometer
InterventionsOocyte quality assessment using spectrophotometer (Procedure)
Datesstart 2024-09-22, primary completion 2025-12-16, completion 2026-11-01 (estimated), first posted 2026-01-09, last updated 2026-01-09
Locations1 site in Israel

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
follicular fluid evaluation using spectrophotometer to differentiate high low quality oocytesExperimentalProcedure: Oocyte quality assessment using spectrophotometer
  • 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- 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

+Outcome measures

Primary outcomes

  • Difference in follicular fluid infrared spectrophotometric profiles between high-quality and low-quality oocytes. [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.

+Eligibility

Sex: Female

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.

+Locations (1)

FacilityCityCountryStatus
Hille Yaffe Medical CenterHadera, IsraelIsrael