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OpenTrials
Completed

NCT Number: NCT04392661

Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up

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.

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Key information

Conditions

Female Fertility and Bariatric Surgery

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

bariatric surgeries and data collection

Other names: Laparoscopic Roux-en-Y Gastric Bypass

Primary outcomes

  1. Measuring the number of females that got pregnant from79 females seeking pregnancy

    Time frame: Five years follow-up

    effect of LSG and LRYGB on female fertility and getting pregnant

  2. percentage excess weight loss after bariatric surgery

    Time frame: Five years follow-up

    effect of LSG and LRYGB on percentage excess weight loss after bariatric surgery on females

Secondary outcomes

  1. comorbidity improvement or resolution after bariatric surgery

    Time frame: Five years follow-up

    effect of LSG and LRYGB on comorbidities on females

  2. postoperative complications or mortality after bariatric surgery

    Time frame: Five years follow-up

    postoperative complications or mortality after LSG and LRYGB in obese females

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2019
First posted
May 19, 2020
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.