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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Procedure: Laparoscopic ovarian diathermy

Primary Measures

• Pregnancy rates

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 39 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Overall Clinical Trial Officials and Contacts

Saad AK Amer, MD Principal Investigator University of Sheffield  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00220545

Study ID Number: 01/173

ClinicalTrials.gov Identifier: NCT00220545

Health Authority: United Kingdom: National Health Service