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Weight Reduction Surgery and Ovarian Function

This study is currently recruiting participants.
Verified by Sheffield Teaching Hospitals NHS Foundation Trust, September 2006

Sponsored by: Sheffield Teaching Hospitals NHS Foundation Trust
Information provided by: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00292773
  Purpose

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.


Condition Intervention
Anovulation
Obesity
Procedure: weight reduction minimal access surgery

MedlinePlus related topics:   Obesity    Weight Control   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:   The Effect of Weight Reduction Surgery on Ovarian Function in Obese Anovulatory Patients

Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Estimated Enrollment:   30
Study Start Date:   February 2006
Estimated Study Completion Date:   February 2008

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 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:

  1. Weight, menstrual diary.
  2. Hormonal profile (FSH/LH, fasting Insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and ghrelin levels).
  3. Doppler of ovarian stroma (Pulsitility index, Peak velocity), ovarian volume and antral follicle count
  4. Review of symptomatology especially androgenic symptoms.

End point:

Completion of six months follow up.

  Eligibility
Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. 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.
  2. BMI of 35 or more.
  3. Age between 18 and 45.

Exclusion Criteria:

  1. Contraindication for bypass surgery:

    i. Medically unfit ii. Psychologically unfit iii. Strong family history of gastric cancer

  2. Insulin dependant diabetes or patients on oral hypoglycaemics. Insulin resistance and impaired glucose tolerance however, are not exclusion criteria.
  3. Concomitant endocrine disorders including thyroid disease and Cushing syndrome.
  4. Patients on steroid therapy.
  5. Patients who have had one or both ovaries removed.
  6. Biochemical evidence of ovarian failure i.e. FSH of 20 IU or more.
  7. Patients who have had hysterectomy.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292773

Contacts
Contact: Dr Mostafa Metwally, MRCOG     m.metwally@sheffield.ac.uk    

Locations
United Kingdom
Jessop Wing, Royal Hallamshire Hospital     Recruiting
      Sheffield, United Kingdom, S10 2SF
      Contact: Dr Mostafa Metwally, MRCOG         m.metwally@shef.ac.uk    

Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust

Investigators
Study Chair:     Professor TC Li, FRCOG,MD     STH    
Study Chair:     Professor William Ledger, FRCOG,D Phil     Sheffield University    
  More Information

Study ID Numbers:   STH14006
First Received:   February 15, 2006
Last Updated:   September 11, 2006
ClinicalTrials.gov Identifier:   NCT00292773
Health Authority:   United Kingdom: Research Ethics Committee

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Anovulation  
Obesity  
bariatric surgery  

Study placed in the following topic categories:
Obesity
Gonadal Disorders
Endocrine System Diseases
Overweight
Ovarian Diseases
Body Weight
Genital Diseases, Female
Signs and Symptoms
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Endocrinopathy
Anovulation

Additional relevant MeSH terms:
Adnexal Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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