Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up
May 22, 2020 updated by: Mohamed Ali Shehata, Tanta University
Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up, Single Center Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
197
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
18 years to 40 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
In the LSG group, 14 patients (12.6%) suffered from infertility, and 24 patients (21.6%) were at pre-marriage stage.
This is versus 15 patients (17.4%), and 26 patients (30.2%) in the LRYGB group respectively.
Description
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:
-
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 |
|---|---|
|
Laparoscopic Sleeve Gastrectomy (group I)
111 morbid obese females underwent LSG (group I).
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.
|
bariatric surgeries and data collection
Other Names:
|
|
Laparoscopic Roux-en-Y Gastric Bypass (group II)
86 morbid obese females underwent 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.
|
bariatric surgeries and data collection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Five years follow-up
|
|
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
|
Five years follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
comorbidity improvement or resolution after bariatric surgery
Time Frame: Five years follow-up
|
effect of LSG and LRYGB on comorbidities on females
|
Five years follow-up
|
|
postoperative complications or mortality after bariatric surgery
Time Frame: Five years follow-up
|
postoperative complications or mortality after LSG and LRYGB in obese females
|
Five years follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2012
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
August 1, 2019
Study Registration Dates
First Submitted
May 14, 2020
First Submitted That Met QC Criteria
May 14, 2020
First Posted (Actual)
May 19, 2020
Study Record Updates
Last Update Posted (Actual)
May 27, 2020
Last Update Submitted That Met QC Criteria
May 22, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Fertility & bariatric surgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.