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IVFIVFNCT06331481

The Effect of Over Weight on Oocytes Quality in IVF Patients

An observational study of IVF and Overweight, run by Hillel Yaffe Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Obesity is an increasing worldwide problem and a risk factor for many diseases. The effect of obesity on female fertility has been extensively tested. Obese women have increased time to pregnancy and remain subfertile even in the absence of ovulatory dysfunction. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
IVF, Overweight
What is being tested?
Fullicular fluid for cytology and biocemical analysis
How many people
50 participants
Where
1 siteIsrael
Study dates
1 Feb 2022to 7 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

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 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: IVF patients who undergo oocyte retrieval

Who may be able to join

  • All women divided by BMI below 25 and above 25 who underwent IVF-ICSI treatment.
  • Consent to participate in the study.

Who cannot join

  • Patients older than 40 years
  • Fertility preservation
  • Unbalanced endocrine disorders
  • Less than 4 follicles at the time of oocyte pick-up

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Hillel Yaffe Medical Center - IVF Unit

    Hadera, 38100

Other trials in Israel

About this study

Obesity is an increasing worldwide problem and a risk factor for many diseases. The effect of obesity on female fertility has been extensively tested. Obese women have increased time to pregnancy and remain subfertile even in the absence of ovulatory dysfunction. They present with higher incidence of infertility compared to normal weight women.

This study is prospective observational cohort study performed between February 2022 until June 2022 in a single university-affiliated hospital.

Read the detailed description

The effect of obesity on female fertility has been extensively tested. Obese women have increased time to pregnancy and remain subfertile even in the absence of ovulatory dysfunction. They present with higher incidence of infertility compared to normal weight women. Furthermore, obesity affects the outcome of fertility treatments, resulting in decreased ovarian response to stimulation, lower quantity and quality of oocytes, and adverse effects on the quality of embryos including lower blastocyst formation and on the chances of conception.

Subfertility and infertility research are aiming to find different markers that may shed light about oocyte quality. It is known that follicular fluid is the microenvironment of the oocyte. Both cumulus cells (CCs) and follicular fluid (FF) are critical determinants for oocyte and reflect its quality.

The oocyte in the ovary develops with the support of cumulus and granulosa cells, which are in close contact with her by gap junction. The oocytes are known to be unable to synthesize their own cholesterol and have very poor glucose metabolism to produce energy. The oocytes are supported for this purpose by cumulus and granulosa cells, and they basically reflect the quality of the oocytes. Evaluating different markers in the follicular fluid and cumulus cells including mitochondrial-DNA and protein that are known to be biomarkers of quality may help us to understand the impact of obesity on oocyte quality without harming the valuable resource.

In this study, the investigators aimed to evaluate the impact of obesity on oocyte quality using 2 main factors reflecting oocyte quality mtDNA levels in CCs and levels of proteins BMP-15 and HSPG2 in FFs.

Women younger than age 41 years, undergoing IVF/IVF-ICSI cycles, participated in the study. Patients were allocated into two BMI groups (<25 and >30) based on WHO criteria to evaluate distinctly different groups. The attending physician determined each patient's care plan without any relation to study recruitment. At the time of ultrasound-guided transvaginal ovum pick-up (OPU), only patients with four or more follicles were recruited. Demographic information was recorded from the electronic medical records, including demographics and obstetrical history (age, parity, BMI, number of previous pregnancies and abortions, prior IVF/ICSI cycles, and biochemical and basal hormonal profile), cycle characteristics (the stimulation protocol, endometrial thickness, and E2, LH and progesterone levels on hCG administration day), cycle outcomes (fertilization rate, number of oocytes, transferred and frozen embryos) and treatment outcomes (chemical and clinical pregnancy rate). Women who had undergone fertility preservation or had comorbidities, such as endocrine disorders, cancer, or other chronic diseases, were excluded.

Conditions
IVF, Overweight
Being tested
Fullicular fluid for cytology and biocemical analysis
Medical subject headings
Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fullicular fluid for cytology and biocemical analysisOther

    The fullicular fluid in the oocyte retrieval process is consider to medical waste. This fluid contains a verity of proteins, mitochondria and verity of cells.

    The investigators using this fluid to learn about the evironment of the oocyte and its quality.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact of obesity on oocyte's mtDNA expression in Cumulus Cells

    How obesity impacts oocyte quality through analysis of mtDNA expression in Cumulus Cells

    Measured: 6 months

  2. Impact of obesity on oocyte quality through levels of protein BMP-15

    How obesity impacts oocyte quality through analysis of levels of protein BMP-15 in Follicular fluid.

    Measured: 6 months

  3. Impact of obesity on oocyte quality through levels of protein HSPG2

    How obesity impacts oocyte quality through analysis of levels of protein HSPG2 in Follicular fluid.

    Measured: 6 months

Secondary outcomes (3)
  1. Impact of obesity on fertilization and pregnancy rates through analysis of mtDNA expression

    How obesity impacts fertilization and pregnancy rates through analysis of mtDNA expression in Cumulus Cells

    Measured: 18 months

  2. Impact of obesity on fertilization and pregnancy rates through levels of protein BMP-15

    How obesity impacts fertilization and pregnancy rates through analysis of levels of protein BMP-15 in Follicular fluid.

    Measured: 18 months

  3. Impact of obesity on fertilization and pregnancy rates through levels of protein HSPG2

    How obesity impacts fertilization and pregnancy rates through analysis of levels of protein HSPG2 in Follicular fluid.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2024
  2. Study start1 Feb 2022
  3. Primary completion7 Jan 2025
  4. Study completion7 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06331481
Sponsor's protocol ID
0005-22-HYMC
Acronym
IVF
Status last verified
May 2025
First submitted
7 Mar 2024
Last updated
9 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of IVF and Overweight, 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 9 May 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Impact of obesity on oocyte's mtDNA expression in Cumulus Cells (time frame: 6 months). The study lists 3 primary outcomes in all. 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 May 2025.

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