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

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

Condition Intervention
Polycystic Ovary Syndrome
Procedure: Laparoscopic ovarian diathermy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Pregnancy rates

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

Estimated Enrollment: 72
Study Start Date: March 2002
Estimated Study Completion Date: March 2006

Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00220545

United Kingdom
Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S10 2SF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Principal Investigator: Saad AK Amer, MD University of Sheffield
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00220545     History of Changes
Other Study ID Numbers: 01/173
Study First Received: September 14, 2005
Last Updated: October 22, 2007

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Polycystic ovarY
Laparoscopic ovarian diathermy
Induction of ovulation
Clomiphene citrate

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017