Oocyte Quality Assessment Using SpectrophotometerNCT07329998
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.
A study testing Oocyte quality assessment using spectrophotometer in people with Oocyte Quality Assessment Using Spectrophotometer, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Oocyte Quality Assessment Using Spectrophotometer
- What is being tested?
- Oocyte quality assessment using spectrophotometer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Sep 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Oocyte quality assessment using spectrophotometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte quality assessment using spectrophotometerProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| follicular fluid evaluation using spectrophotometer to differentiate high low quality oocytes | Experimental | Not described Receives: Procedure: Oocyte quality assessment using spectrophotometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start22 Sep 2024
- Primary completion16 Dec 2025
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte Quality Assessment Using SpectrophotometerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329998
- Sponsor's protocol ID
- 0069-23-HYMC
- Status last verified
- Jan 2026
- First submitted
- 16 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oocyte Quality Assessment Using Spectrophotometer
- ClinicalTrials.gov ID
- NCT07329998
- Acronym / sponsor ID
- 0069-23-HYMC
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 22 Sep 2024 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| follicular fluid evaluation using spectrophotometer to differentiate high low quality oocytes | Experimental | Procedure: Oocyte quality assessment using spectrophotometer |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oocyte quality assessment using spectrophotometerOn 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 | Procedure or surgery | follicular fluid evaluation using spectrophotometer to differentiate high low quality oocytes |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oocyte quality assessment using spectrophotometer in people with Oocyte Quality Assessment Using Spectrophotometer, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in follicular fluid infrared spectrophotometric profiles between high-quality and low-quality oocytes. (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.