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Sponsors and Collaborators: |
Sheffield Teaching Hospitals NHS Foundation Trust University of Sheffield |
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Information provided by: | Sheffield Teaching Hospitals NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00220545 |
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 |
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Polycystic Ovary Syndrome |
Procedure: Laparoscopic ovarian diathermy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Ages Eligible for Study: | 19 Years to 39 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, South Yorkshire | |
Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust | |
Sheffield, South Yorkshire, United Kingdom, S10 2SF |
Principal Investigator: | Saad AK Amer, MD | University of Sheffield |
Study ID Numbers: | 01/173 |
Study First Received: | September 14, 2005 |
Last Updated: | October 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00220545 History of Changes |
Health Authority: | United Kingdom: National Health Service |
Polycystic ovarY Laparoscopic ovarian diathermy Induction of ovulation Clomiphene citrate |
Infertility Estrogen Antagonists Estrogens Gonadal Disorders Hormone Antagonists Citric Acid Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Clomiphene Ovarian Diseases |
Selective Estrogen Receptor Modulators Cysts Hormones Polycystic Ovarian Syndrome Genital Diseases, Female Estrogen Receptor Modulators Polycystic Ovary Syndrome Endocrinopathy Ovarian Cysts |
Estrogen Antagonists Disease Gonadal Disorders Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Clomiphene Reproductive Control Agents Ovarian Diseases Selective Estrogen Receptor Modulators Cysts |
Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Estrogen Receptor Modulators Neoplasms Pathologic Processes Therapeutic Uses Fertility Agents, Female Syndrome Fertility Agents Polycystic Ovary Syndrome Ovarian Cysts |