Obesity and Intracytoplasmic Sperm Injection Cycle Outcome

NCT ID: NCT03778684

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-11-26

Brief Summary

Obesity has been associated with menstrual irregularities, chronic an-ovulation, infertility, and poor outcomes in women undergoing in vitro fertilization.

There is strong evidence that obesity is associated with a higher n vitro fertilization cycle cancellation rate (despite administration of higher doses of exogenous gonadotrophins), a lower mature oocyte yield and lower number of cryopreservation cycles.

Furthermore, obese women have been shown to have impaired response to ovarian stimulation and significantly lower live births after in vitro fertilization. Indeed, obesity affects many ovarian intra-follicular steroidogenic, metabolic and inflammatory pathways.This is particularly evident in women with abdominal (central obesity). Waist circumference measurement is used to identify individuals with abdominal obesity but it cannot differentiate between intra-abdominal fat and subcutaneous abdominal fat accumulation.

The reliable measurement of visceral fat and subcutaneous fat is not only important as a tool to predict cardiovascular and metabolic disease risk, but it is also essential to evaluate the effect of these fat compartments on female reproductive function. Intra-abdominal fat accumulation is related to insulin resistance in women with polycystic ovary syndrome and in these women the resulting hyperinsulinemia contributes to an-ovulation.

Obese anovulatory women with polycystic ovary syndrome who resume ovulation during a 6-month lifestyle program lose more visceral fat with no difference in the change of subcutaneous fat compared to the women who did not resume ovulation.

Another recent study that enrolled 140 non-polycystic ovary syndrome in vitro fertilization women demonstrated that women with increased waist circumference and higher follicular fluid leptin have less oocytes fertilized and failed in vitro fertilization outcomes. Increased intra-abdominal fat during early pregnancy is associated with insulin resistance and increased diastolic blood pressure and it can predict glucose intolerance in later pregnancy.

Conditions

Infertility

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Normal Body mass index without central obesity

Group Type: EXPERIMENTAL

Visceral fat thickness

Intervention Type: DIAGNOSTIC_TEST

An initial longitudinal sweep will be done from the xiphoid process to the umbilicus to determine the area of maximum pre-peritoneal fat thickness.

Body mass index

Intervention Type: DIAGNOSTIC_TEST

Weight and height will be measured with subjects in a standing position wearing light clothes and no shoes.

High Body mass index with central obesity

Group Type: EXPERIMENTAL

Visceral fat thickness

Intervention Type: DIAGNOSTIC_TEST

An initial longitudinal sweep will be done from the xiphoid process to the umbilicus to determine the area of maximum pre-peritoneal fat thickness.

Body mass index

Intervention Type: DIAGNOSTIC_TEST

Weight and height will be measured with subjects in a standing position wearing light clothes and no shoes.

Interventions

Visceral fat thickness

An initial longitudinal sweep will be done from the xiphoid process to the umbilicus to determine the area of maximum pre-peritoneal fat thickness.

Intervention Type: DIAGNOSTIC_TEST

Body mass index

Weight and height will be measured with subjects in a standing position wearing light clothes and no shoes.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age of women 18 - 35 yrs old.
• Women with Body mass index I 18 - 35 kg/m2.
• Infertile women with an indication for In vitro fertilization
• Anticipated normal responders.
• Normal uterine cavity by trans-vaginal ultrasound.

Exclusion Criteria

• Poly cystic ovarian syndrome
• Diabetic patients.
• Known Poor ovarian response
• Patients with abnormal uterine cavity.
• Refusal to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Ahmad Mohamed Makhlouf

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women Health Hospital - Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

ICSI-Alaa

Identifier Type: -

Identifier Source: org_study_id