Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up

Female Fertility and Bariatric Surgery Clinical Trial

Official title:

Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up, Single Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392661
• Other study ID #: Fertility & bariatric surgery
• Status: Completed
• Start date: January 2012
• Est. completion date: August 2019

Study information

• Verified date: May 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Maternal morbid obesity is an important risk factor in modern obstetrics, it has been associated with higher infertility rates and obstetrics complications. Bariatric surgery proven to achieve long term weight loss with improvement in all obesity related morbidities. This study was to compare the 5 years outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) in terms of fertility outcomes, breast feeding, weight loss, safety, and resolution of obesity related co-morbidity.

Description:

This study included 197 adult morbidly obese females, 111 underwent LSG (group I) and 86 LRYGB (group II). After 5 years follow up, the following were looked at: percentage excess weight loss (%EWL), comorbidity improvement or resolution, postoperative complications or mortality, fertility outcomes and breast feeding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: August 2019
• Est. primary completion date: December 2014
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients with primary goal of conceiving and complaining from infertility either primary or secondary as well as those who were seeking weight loss in preparation for marriage

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Female Fertility and Bariatric Surgery

Intervention

Procedure:
• Laparoscopic Sleeve Gastrectomy
bariatric surgeries and data collection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring the number of females that got pregnant from79 females seeking pregnancy	effect of LSG and LRYGB on female fertility and getting pregnant	Five years follow-up
Primary	percentage excess weight loss after bariatric surgery	effect of LSG and LRYGB on percentage excess weight loss after bariatric surgery on females	Five years follow-up
Secondary	comorbidity improvement or resolution after bariatric surgery	effect of LSG and LRYGB on comorbidities on females	Five years follow-up
Secondary	postoperative complications or mortality after bariatric surgery	postoperative complications or mortality after LSG and LRYGB in obese females	Five years follow-up