Impact of Bariatric Surgery on Women Fertility | NCT05457413

Studies
Impact of Bariatric Surgery on Women Fertility

NCT05457413

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Apr 19, 2023Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Fertility Issues

Interventions

Sleeve gastrectomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2022Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Jul 5, 2022

First Submission Date that Met QC Criteria

Jul 13, 2022

First Posted Date

Jul 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2023

Last Update Posted Date

Apr 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sleeve gastrectomy		Sleeve gastrectomy for weight loss	Procedure: Sleeve gastrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleeve gastrectomy	Procedure	Bariatric surgery	Sleeve gastrectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in serum FSH level		3 months
Change in serum LH level		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Obese females undergoing sleeve gastrectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maii Nawara	Associate professor	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University Maternity Hospital		Cairo	Cairo/القاهرة	71350	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Will be availabe after publishing for 2 years

Access Criteria

Will be with corresponding author if required

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided