Impact of Bariatric Surgery on Women Fertility

April 17, 2023 updated by: Ain Shams University

Impact of Bariatric Surgery Induced Weight Loss on Women Fertility: A Prospective Cohort Study

Obesity is a multifactorial risk factor for subfertility, in relation to chronic hormonal change induced by adipose tissue. This prospective cohort study aims to evaluate the impact of bariatric surgery induced weight loss on women fertility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Females undergoing sleeve gastrectomy will be assessed for improvement of fertility indicators

Study Type

Observational

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo/القاهرة
      • Cairo, Cairo/القاهرة, Egypt, 71350
        • Ain Shams University Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Obese females undergoing sleeve gastrectomy

Description

Inclusion Criteria:

  • Age from 20-40 years.
  • BMI >35 kg/m2

Exclusion Criteria:

  • Women with medical endocrinal disorders as DM, thyroid, hyperprolactinaemia, etc.
  • Women using any hormonal treatment or fertility drugs like oral contraceptive pills and/or metformin.
  • Women have any surgical complication intra-operatively or post operatively.
  • Women refused to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sleeve gastrectomy
Sleeve gastrectomy for weight loss
Procedure: Sleeve gastrectomy
Bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Antimullerian hormone level
Time Frame: 3 months
Change in antimullerian hormone level
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum FSH level
Time Frame: 3 months
3 months
Change in serum LH level
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Maii Nawara, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS 392/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymous participants data will be available with principal investigator and director for any inquiries

IPD Sharing Time Frame

Will be availabe after publishing for 2 years

IPD Sharing Access Criteria

Will be with corresponding author if required

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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