Obesity and Intracytoplasmic Sperm Injection Cycle Outcome

NCT03778684 | Completed

• 1 other identifier: ICSI-Alaa
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of women will be pregnant (clinical pregnancy rate)

  a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy.

  1 month

Study Arms (2)

Normal Body mass index without central obesity

EXPERIMENTAL

Diagnostic Test: Visceral fat thickness; Diagnostic Test: Body mass index

High Body mass index with central obesity

EXPERIMENTAL

Diagnostic Test: Visceral fat thickness; Diagnostic Test: Body mass index

Interventions

Visceral fat thickness 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.

High Body mass index with central obesity; Normal Body mass index without central obesity

Body mass index 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; Normal Body mass index without central obesity

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Body Mass Index

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 19, 2018
• Study Start: February 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: November 26, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

EG (1)