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Obesity Index That Better Predict Ovarian Response

Sponsor
Ain Shams University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02520765
Collaborator
(none)
500
Enrollment
1
Location
23
Duration (Months)
21.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to assess the accuracy of Body Mass Index ,Waist Circumference ,Waist Hip Ratio or Waist Height Ratio as a predictor of ovarian response in women undergoing ICSI.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Obesity is an increasingly serious health concern worldwide, and its association with many diseases has been demonstrated. Obesity as it relates to infertility is also being studied All these studies used body mass index (BMI) to determine obesity. Although it is the most commonly used parameter to measure obesity, BMI does not provide an accurate measure of a person's body composition, including body fat.

    Almost all studies conducted on this subject used body mass index (BMI) as the measure of obesity; however, using only BMI might be the wrong strategy. Interestingly, some studies on the cardiovascular system found protective effects of BMI and as a result a new term, 'obesity paradox,' emerged. Later studies used waist-to-hip (W/H) ratio and wrist circumference (WC) as a measure of obesity, and showed the exact effect of body fat distribution and obesity on the cardiovascular system

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Obesity Index That Better Predict Ovarian Response: Body Mass Index, Waist Circumference, Waist Hip Ratio, or Waist Height Ratio in Women Undergoing ICSI
    Study Start Date :
    Oct 1, 2015
    Anticipated Primary Completion Date :
    Aug 1, 2017
    Anticipated Study Completion Date :
    Sep 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. number of oocytes [1 month]

      number f oocytes counted at the oocyte retrieval day during ICSI

    Secondary Outcome Measures

    1. clinical pregnancy rate [7 Weeks]

      detection of fetal cardiac activity by transvaginal ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients scheduled for ICSI
    Exclusion Criteria:

    • Poor Responders.

    • Poly cystic ovary syndrome.

    • Previous ovarian surgeries.

    • Patients with ovarian cysts

    • patients with endometriosis

    • women age more than 35 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Ain Shams University Cairo Al Qahirah Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Ahmed dr kotb, MD, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Mohamed El Kotb Abdel Fattah, Doctor, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT02520765
    Other Study ID Numbers:
    • obesity index in ICSI
    First Posted:
    Aug 13, 2015
    Last Update Posted:
    Aug 16, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Ahmed Mohamed El Kotb Abdel Fattah, Doctor, Ain Shams University
    Obesity Index, ICSI
    Additional relevant MeSH terms:
    Infertility
    Obesity

    Study Results

    No Results Posted as of Aug 16, 2017