Status:
COMPLETED
Weight Reduction Surgery and Ovarian Function
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Anovulation
Obesity
Eligibility:
FEMALE
18-45 years
Brief Summary
This study will investigate the role of weight reduction surgery on the reproductive performance of obese women with ovulation problems. It is hypothesized that surgery offered when other methods of w...
Detailed Description
We aim to recruit 30 patients suffering from chronic anovulation, with a body mass index of 35 or more, who failed to achieve weight reduction with other methods such as orlistat, metformin, diet and ...
Eligibility Criteria
Inclusion
- Anovulation or irregular ovulation as determined by the following clinical or laboratory features:
- Clinical:
- i. Irregular cycles (not 25-35 days) ii. Amenorrhoea (more than six months).
- Biochemical: Day 21 or midleuteal serum progesterone of less than 30mmol/l.
- BMI of 35 or more.
- Age between 18 and 45.
Exclusion
- Contraindication for bypass surgery:
- i. Medically unfit ii. Psychologically unfit iii. Strong family history of gastric cancer
- Insulin dependant diabetes or patients on oral hypoglycaemics. Insulin resistance and impaired glucose tolerance however, are not exclusion criteria.
- Concomitant endocrine disorders including thyroid disease and Cushing syndrome.
- Patients on steroid therapy.
- Patients who have had one or both ovaries removed.
- Biochemical evidence of ovarian failure i.e. FSH of 20 IU or more.
- Patients who have had hysterectomy.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00292773
Start Date
February 1 2006
End Date
February 1 2008
Last Update
July 20 2011
Active Locations (1)
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1
Jessop Wing, Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2SF