Skip to main content
OpenTrials
Completed

NCT Number: NCT00220545

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2SF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic ovarian diathermy

Procedure

Primary outcomes

  1. Pregnancy rates

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • University of Sheffield

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.