Clinical trial NCT06331481: The Effect of Over Weight on Oocytes Quality in IVF Patients
Official title: The Effect of Over Weight on Oocytes Quality in IVF Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IVF
Overweight
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-03-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IVF patients who undergo oocyte retrieval

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of obesity on oocyte's mtDNA expression in Cumulus Cells
timeFrame: 6 months
measure: Impact of obesity on oocyte quality through levels of protein BMP-15
timeFrame: 6 months
measure: Impact of obesity on oocyte quality through levels of protein HSPG2
timeFrame: 6 months
Secondary outcomes:
measure: Impact of obesity on fertilization and pregnancy rates through analysis of mtDNA expression
timeFrame: 18 months
measure: Impact of obesity on fertilization and pregnancy rates through levels of protein BMP-15
timeFrame: 18 months
measure: Impact of obesity on fertilization and pregnancy rates through levels of protein HSPG2
timeFrame: 18 months
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center - IVF Unit
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Einat Shalom-Paz, p
role: PRINCIPAL_INVESTIGATOR
References: