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.
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.
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.
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
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
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)
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
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
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.
- First posted26 Mar 2024
- Study start1 Feb 2022
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Einat Shalom-Paz, p, Principal investigator, Hillel Yaffe Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Over Weight on Oocytes Quality in IVF Patients
- ClinicalTrials.gov ID
- NCT06331481
- Acronym / sponsor ID
- IVF / 0005-22-HYMC
- Conditions
- IVF, Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 26 Mar 2024 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- IVF patients who undergo oocyte retrieval
Key inclusion criteria (2 listed)
- All women divided by BMI below 25 and above 25 who underwent IVF-ICSI treatment.
- Consent to participate in the study.
Key exclusion criteria (4 listed)
- Patients older than 40 years
- Fertility preservation
- Unbalanced endocrine disorders
- Less than 4 follicles at the time of oocyte pick-up
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 |
|---|---|---|
| Fullicular fluid for cytology and biocemical analysisThe 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. | Other | – |
Primary outcome
Impact of obesity on oocyte's mtDNA expression in Cumulus Cells
Time frame: 6 months
How obesity impacts oocyte quality through analysis of mtDNA expression in Cumulus Cells
Impact of obesity on oocyte quality through levels of protein BMP-15
Time frame: 6 months
How obesity impacts oocyte quality through analysis of levels of protein BMP-15 in Follicular fluid.
Impact of obesity on oocyte quality through levels of protein HSPG2
Time frame: 6 months
How obesity impacts oocyte quality through analysis of levels of protein HSPG2 in Follicular fluid.
3 secondary outcomes
Impact of obesity on fertilization and pregnancy rates through analysis of mtDNA expression
Time frame: 18 months
Impact of obesity on fertilization and pregnancy rates through levels of protein BMP-15
Time frame: 18 months
Impact of obesity on fertilization and pregnancy rates through levels of protein HSPG2
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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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.
Einat Shalom-Paz, p principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
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.