NCT00292773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

First QC Date

February 15, 2006

Last Update Submit

July 19, 2011

Conditions

AnovulationObesity

Keywords

AnovulationObesitybariatric surgery

Interventions

weight reduction minimal access surgeryPROCEDURE

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Obese anovulatory women.

You may qualify if:

  • 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.

You may not qualify if:

  • Contraindication for bypass surgery:
  • i. Medically unfit ii. Psychologically unfit iii. Strong family history of gastric cancer
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessop Wing, Royal Hallamshire Hospital

Sheffield, S10 2SF, United Kingdom

Location

MeSH Terms

Conditions

AnovulationObesity

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Professor TC Li, FRCOG,MD

    STH

    STUDY CHAIR

  • Professor William Ledger, FRCOG,D Phil

    Sheffield University

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2006

First Posted

February 16, 2006

Study Start

February 1, 2006

Study Completion

February 1, 2008

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

GB(1)