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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220545
• Other study ID #: STH5735 01/173
• Status: Completed
• Phase: N/A
• Start date: March 2002
• Est. completion date: March 2006

Study information

• Verified date: May 2024
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperthermia
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Procedure:
• Laparoscopic ovarian diathermy

Locations

Country	Name	City	State
United Kingdom	Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rates
Secondary	Ovulation, Pregnancy outcome (especially miscarriage), Menstrual pattern, Endocrine changes, Side effects / complications rate