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Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Laparoscopic ovarian diathermy
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovarY, Laparoscopic ovarian diathermy, Induction of ovulation, Clomiphene citrate

Eligibility Criteria

19 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age: 19 - 39 BMI < 32 Anovulatory Infertility > 1 year Diagnostic criteria for No previous treatment for induction of ovulation Normal semen analysis of partner Proven patency of at least one Fallopian tube Exclusion Criteria: Inability to give informed consent Contraindication to CC Contraindication to general anaesthetic or laparoscopy

Sites / Locations

  • Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust

Outcomes

Primary Outcome Measures

Pregnancy rates

Secondary Outcome Measures

Ovulation, Pregnancy outcome (especially miscarriage), Menstrual pattern, Endocrine changes, Side effects / complications rate

Full Information

First Posted
September 14, 2005
Last Updated
October 22, 2007
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield
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1. Study Identification

Unique Protocol Identification Number
NCT00220545
Brief Title
Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS
Official Title
A Prospective Randomized Controlled Trial to Compare Laparoscopic Ovarian Diathermy With Clomiphene Citrate as a First Line Treatment of Anovulatory Infertility in Patients With Polycystic Ovarian Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield

4. Oversight

5. Study Description

Brief Summary
Laparoscopic ovarian diathermy (LOD) is currently offered to infertile women with polycystic ovarian syndrome (PCOS) who fail to conceive on clomiphene citrate (CC). However, using LOD before CC may result in a better reproductive outcome since LOD may reduce risks associated with CC such as miscarriages and multiple pregnancies. The aim of the study is to evaluate the effectiveness of LOD and its potential value in improving the success rates in infertile women with PCOS. This study will recruit 72 women with PCOS suffering from infertility due to lack of ovulation from the infertility clinic. After initial assessment, patients will be given explanation about the study and will receive an information leaflet. They will then be randomized into two groups: Group1 (36 patients) will receive CC as per infertility clinic protocol to induce ovulation for up to 6 months. Group 2 (36 patients) will undergo laparoscopic ovarian diathermy under general anaesthetic. Blood samples will be taken from both groups before any treatment, shortly after treatment and at 3 and 6 months after treatment to measure various hormones. Patients will be contacted every month after treatment for follow up. The reproductive outcomes particularly the pregnancy and livebirth rates will be compared between the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovarY, Laparoscopic ovarian diathermy, Induction of ovulation, Clomiphene citrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ovarian diathermy
Primary Outcome Measure Information:
Title
Pregnancy rates
Secondary Outcome Measure Information:
Title
Ovulation, Pregnancy outcome (especially miscarriage), Menstrual pattern, Endocrine changes, Side effects / complications rate

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 19 - 39 BMI < 32 Anovulatory Infertility > 1 year Diagnostic criteria for No previous treatment for induction of ovulation Normal semen analysis of partner Proven patency of at least one Fallopian tube Exclusion Criteria: Inability to give informed consent Contraindication to CC Contraindication to general anaesthetic or laparoscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad AK Amer, MD
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2SF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18794162
Citation
Amer SA, Li TC, Metwally M, Emarh M, Ledger WL. Randomized controlled trial comparing laparoscopic ovarian diathermy with clomiphene citrate as a first-line method of ovulation induction in women with polycystic ovary syndrome. Hum Reprod. 2009 Jan;24(1):219-25. doi: 10.1093/humrep/den325. Epub 2008 Sep 14.
Results Reference
derived

Learn more about this trial

Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS

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