NCT05457413

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 19, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

July 5, 2022

Last Update Submit

April 17, 2023

Conditions

Fertility Issues

Outcome Measures

Primary Outcomes (1)

  • Change in Antimullerian hormone level

    Change in antimullerian hormone level

    3 months

Secondary Outcomes (2)

  • Change in serum FSH level

    3 months

  • Change in serum LH level

    3 months

Study Arms (1)

Sleeve gastrectomy

Sleeve gastrectomy for weight loss

Procedure: Sleeve gastrectomy

Interventions

Sleeve gastrectomyPROCEDURE

Bariatric surgery

Sleeve gastrectomy

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Obese females undergoing sleeve gastrectomy

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Cairo/القاهرة, 71350, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Maii Nawara

    Associate professor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 14, 2022

Study Start

July 25, 2022

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

April 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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

Time Frame
Will be availabe after publishing for 2 years
Access Criteria
Will be with corresponding author if required

Locations

EG(1)