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

This study has been completed.
Sponsor:
Collaborator:
University of Sheffield
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220545
First received: September 14, 2005
Last updated: October 22, 2007
Last verified: October 2007

September 14, 2005
October 22, 2007
March 2002
Not Provided
Pregnancy rates
Same as current
Complete list of historical versions of study NCT00220545 on ClinicalTrials.gov Archive Site
Ovulation, Pregnancy outcome (especially miscarriage), Menstrual pattern, Endocrine changes, Side effects / complications rate
Same as current
Not Provided
Not Provided
 
Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Ovary Syndrome
Procedure: Laparoscopic ovarian diathermy
Not Provided
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. Epub 2008 Sep 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
March 2006
Not Provided

Inclusion Criteria:

  1. Age: 19 - 39
  2. BMI < 32
  3. Anovulatory Infertility > 1 year
  4. Diagnostic criteria for
  5. No previous treatment for induction of ovulation
  6. Normal semen analysis of partner
  7. Proven patency of at least one Fallopian tube

Exclusion Criteria:

  1. Inability to give informed consent
  2. Contraindication to CC
  3. Contraindication to general anaesthetic or laparoscopy
Female
19 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00220545
01/173
Not Provided
Not Provided
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Principal Investigator: Saad AK Amer, MD University of Sheffield
Sheffield Teaching Hospitals NHS Foundation Trust
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP