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Obesity and Intracytoplasmic Sperm Injection Cycle Outcome

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Visceral fat thickness
Body mass index
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infertility

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Women Health Hospital - Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normal Body mass index without central obesity

High Body mass index with central obesity

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2018
Last Updated
November 26, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03778684
Brief Title
Obesity and Intracytoplasmic Sperm Injection Cycle Outcome
Official Title
Impact of Obesity on Intracytoplasmic Sperm Injection Cycle Outcome: a Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
November 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Body mass index without central obesity
Arm Type
Experimental
Arm Title
High Body mass index with central obesity
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Visceral fat thickness
Intervention Description
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
Intervention Name(s)
Body mass index
Intervention Description
Weight and height will be measured with subjects in a standing position wearing light clothes and no shoes.
Primary Outcome Measure Information:
Title
Number of women will be pregnant (clinical pregnancy rate)
Description
a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy.
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Obesity and Intracytoplasmic Sperm Injection Cycle Outcome

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