The Effect of Over Weight on Oocytes Quality in IVF Patients

Overweight Clinical Trial

— IVF  

Official title:

The Effect of Over Weight on Oocytes Quality in IVF Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06331481
• Other study ID #: 0005-22-HYMC
• Status: Active, not recruiting
• Start date: February 1, 2022
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. All women divided by BMI below 25 and above 25 who underwent IVF-ICSI treatment.

2. Consent to participate in the study.

Exclusion Criteria:

1. Patients older than 40 years

2. Fertility preservation

3. Unbalanced endocrine disorders

4. Less than 4 follicles at the time of oocyte pick-up

Related Conditions & MeSH terms

• IVF
• Overweight

Intervention

Other:
• Fullicular fluid for cytology and biocemical analysis
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.

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center - IVF Unit	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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	18 months
Secondary	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.	18 months
Secondary	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.	18 months