The Effect of Over Weight on Oocytes Quality in IVF Patients

NCT06331481 | Completed DMC

• 1 other identifier: 0005-22-HYMC
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

IVF; Overweight

Outcome Measures

Primary Outcomes (3)

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

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

  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.

  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.

  6 months

Secondary Outcomes (3)

• Impact of obesity on fertilization and pregnancy rates through analysis of mtDNA expression

  18 months

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

  18 months

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

  18 months

Interventions

Fullicular fluid for cytology and biocemical analysis OTHER

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: IVF patients who undergo oocyte retrieval
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

IVF patients who undergo oocyte retrieval

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe Medical Center - IVF Unit

Hadera, 38100, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fullicular fluid for cytology and biochemical analysis

MeSH Terms

Conditions

Overweight

Interventions

Cytological Techniques

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Einat Shalom-Paz, p

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 26, 2024
• Study Start: February 1, 2022
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

IL (1)