Weight Reduction Surgery and Ovarian Function
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|ClinicalTrials.gov Identifier: NCT00292773|
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : July 20, 2011
|Condition or disease||Intervention/treatment|
|Anovulation Obesity||Procedure: weight reduction minimal access surgery|
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 exercise.
Patients will be approached by one of the investigators in the infertility clinics and the assisted conception unit of the Royal Hallamshire hospital. Consent will be obtained by one of the designated investigators. The consent form has been designed in accordance with the guidelines of the central office for research and ethics committees (COREC). A patient information leaflet will be supplied and has been designed according to the COREC guidelines.
Patients will have a baseline history, clinical examination, hormonal profile (FSH/LH, fasting Insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and ghrelin levels) ultrasound examination (ovarian volume and antral follicle count), including Doppler blood flow study (ovarian stromal velocity).
Patients will be offered laparoscopic gastric bypass surgery by Mr Roger Ackroyd, in line with the current recommendation for gastric surgery according to NICE guidelines i.e. patients with a BMI over 40 or a BMI over 35 with at least one co-morbidity. Patients will be reviewed monthly for six months. At each visit the following will be recorded:
- Weight, menstrual diary.
- Hormonal profile (FSH/LH, fasting Insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and ghrelin levels).
- Doppler of ovarian stroma (Pulsitility index, Peak velocity), ovarian volume and antral follicle count
- Review of symptomatology especially androgenic symptoms.
Completion of six months follow up.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||The Effect of Weight Reduction Surgery on Ovarian Function in Obese Anovulatory Patients|
|Study Start Date :||February 2006|
|Actual Study Completion Date :||February 2008|
Procedure: weight reduction minimal access surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292773
|Jessop Wing, Royal Hallamshire Hospital|
|Sheffield, United Kingdom, S10 2SF|
|Study Chair:||Professor TC Li, FRCOG,MD||STH|
|Study Chair:||Professor William Ledger, FRCOG,D Phil||Sheffield University|