Obesity and Intracytoplasmic Sperm Injection Cycle Outcome

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03778684
Collaborator
(none)
160
1
2
36.9
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Visceral fat thickness
  • Diagnostic Test: Body mass index
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Impact of Obesity on Intracytoplasmic Sperm Injection Cycle Outcome: a Prospective Cohort Study
Actual Study Start Date :
Feb 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Normal Body mass index without central obesity

Diagnostic Test: 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.

Diagnostic Test: Body mass index
Weight and height will be measured with subjects in a standing position wearing light clothes and no shoes.

Experimental: High Body mass index with central obesity

Diagnostic Test: 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.

Diagnostic Test: Body mass index
Weight and height will be measured with subjects in a standing position wearing light clothes and no shoes.

Outcome Measures

Primary Outcome Measures

  1. Number of women will be pregnant (clinical pregnancy rate) [1 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women Health Hospital - Assiut university Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Khairy Ali, Assistant professor, Assiut University
ClinicalTrials.gov Identifier:
NCT03778684
Other Study ID Numbers:
  • ICSI-Alaa
First Posted:
Dec 19, 2018
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2021