Clinical Trial: Weight Reduction Surgery and Ovarian Function
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: The Effect of Weight Reduction Surgery on Ovarian Function in Obese Anovulatory Patients
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 weight reduction have failed, may help restore ovulation.
Detailed Summary:
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 sym
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sheffield Teaching Hospitals NHS Foundation Trust
Dates:
Date Received: February 15, 2006
Date Started: February 2006
Date Completion:
Last Updated: July 19, 2011
Last Verified: July 2011
