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Weight Reduction Surgery and Ovarian Function

This study has been completed.
Sponsor:
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00292773
First received: February 15, 2006
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Effect of Weight Reduction Surgery on Ovarian Function in Obese Anovulatory Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 30
Study Start Date: February 2006
Study Completion Date: February 2008
Intervention Details:
    Procedure: weight reduction minimal access surgery
    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.
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
Sampling Method:   Non-Probability Sample
Study Population

Obese anovulatory women.

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

Locations
United Kingdom
Jessop Wing, Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2SF
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

No publications provided

Responsible Party: Prof Simon Heller, Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00292773     History of Changes
Other Study ID Numbers: STH14006
Study First Received: February 15, 2006
Last Updated: July 19, 2011
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Anovulation
Obesity
Weight Loss
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 21, 2013