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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT00220545
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Study Completion: 2006-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pregnancy rates

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom