NCT07329998

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress82%
Sep 2024Nov 2026

Study Start

First participant enrolled

September 22, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

November 16, 2025

Last Update Submit

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

EXPERIMENTAL
Procedure: Oocyte quality assessment using spectrophotometer

Interventions

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

follicular fluid evaluation using spectrophotometer to differentiate high low quality oocytes

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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

Locations