Female Fertility and Bariatric SurgeryNCT04392661
Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up
An observational study of Female Fertility and Bariatric Surgery, run by Tanta University.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Female Fertility and Bariatric Surgery
- What is being tested?
- Laparoscopic Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 197 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- -
About this study
Official title: 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.
Read the 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.
- Conditions
- Female Fertility and Bariatric Surgery
- Being tested
- Laparoscopic Sleeve Gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve GastrectomyProcedure or surgery
Also called Laparoscopic Roux-en-Y Gastric Bypass
bariatric surgeries and data collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Laparoscopic Sleeve Gastrectomy | |
| 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. Receives: Procedure: Laparoscopic Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the number of females that got pregnant from79 females seeking pregnancy
effect of LSG and LRYGB on female fertility and getting pregnant
Measured: Five years follow-up
percentage excess weight loss after bariatric surgery
effect of LSG and LRYGB on percentage excess weight loss after bariatric surgery on females
Measured: Five years follow-up
Secondary outcomes (2)
comorbidity improvement or resolution after bariatric surgery
effect of LSG and LRYGB on comorbidities on females
Measured: Five years follow-up
postoperative complications or mortality after bariatric surgery
postoperative complications or mortality after LSG and LRYGB in obese females
Measured: Five years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study startJan 2012
- Primary completionDec 2014
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Fertility and Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali Shehata, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392661
- Sponsor's protocol ID
- Fertility & bariatric surgery
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up, Single Center Study
- ClinicalTrials.gov ID
- NCT04392661
- Acronym / sponsor ID
- Fertility & bariatric surgery
- Conditions
- Female Fertility and Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy (group I) | – | Procedure: Laparoscopic Sleeve Gastrectomy111 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. |
| Laparoscopic Roux-en-Y Gastric Bypass (group II) | – | Procedure: Laparoscopic Sleeve Gastrectomy86 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Sleeve GastrectomyAlso: Laparoscopic Roux-en-Y Gastric Bypassbariatric surgeries and data collection | Procedure or surgery | Laparoscopic Roux-en-Y Gastric Bypass (group II), Laparoscopic Sleeve Gastrectomy (group I) |
Primary outcome
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
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
2 secondary outcomes
comorbidity improvement or resolution after bariatric surgery
Time frame: Five years follow-up
postoperative complications or mortality after bariatric surgery
Time frame: Five years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Fertility and Bariatric Surgery, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the number of females that got pregnant from79 females seeking pregnancy (time frame: Five years follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.