Fertility IssuesNCT05457413
Impact of Bariatric Surgery on Women Fertility
An observational study of Fertility Issues, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues
- What is being tested?
- Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2022to 1 Mar 2023
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Obese females undergoing sleeve gastrectomy
Who may be able to join
- Age from 20-40 years.
- BMI >35 kg/m2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Bariatric Surgery Induced Weight Loss on Women Fertility: A Prospective Cohort Study
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.
Read the detailed description
Females undergoing sleeve gastrectomy will be assessed for improvement of fertility indicators
- Conditions
- Fertility Issues
- Being tested
- Sleeve gastrectomy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
Bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy | Sleeve gastrectomy for weight loss Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Antimullerian hormone level
Change in antimullerian hormone level
Measured: 3 months
Secondary outcomes (2)
Change in serum FSH level
Measured: 3 months
Change in serum LH level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start25 Jul 2022
- Primary completion1 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maii Nawara, Study director, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457413
- Sponsor's protocol ID
- MS 392/2022
- Status last verified
- Jan 2023
- First submitted
- 5 Jul 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous participants data will be available with principal investigator and director for any inquiries
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bariatric Surgery Induced Weight Loss on Women Fertility: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05457413
- Acronym / sponsor ID
- MS 392/2022
- Conditions
- Fertility Issues
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 14 Jul 2022 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy | – | Procedure: Sleeve gastrectomySleeve gastrectomy for weight loss |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Obese females undergoing sleeve gastrectomy
Key inclusion criteria (2 listed)
- Age from 20-40 years.
- BMI >35 kg/m2
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Sleeve gastrectomyBariatric surgery | Procedure or surgery | Sleeve gastrectomy |
Primary outcome
Change in Antimullerian hormone level
Time frame: 3 months
Change in antimullerian hormone level
2 secondary outcomes
Change in serum FSH level
Time frame: 3 months
Change in serum LH level
Time frame: 3 months
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 19 Apr 2023.
- Individual participant dataSharing planned: Yes. Anonymous participants data will be available with principal investigator and director for any inquiries
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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.
Maii Nawara study director
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Issues, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 4 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in Antimullerian hormone level (time frame: 3 months). 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 19 Apr 2023.