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Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS
This study has been completed.
First Received: September 14, 2005   Last Updated: October 22, 2007   History of Changes
Sponsors and Collaborators: Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Information provided by: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00220545
  Purpose

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

MedlinePlus related topics: Infertility
Drug Information available for: Clomiphene citrate Zuclomiphene Enclomiphene Citric acid Clomiphene Sodium Citrate trans-Clomifene citrate
U.S. FDA Resources
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

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
  Eligibility

Ages Eligible for Study:   19 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220545

Locations
United Kingdom, South Yorkshire
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
Investigators
Principal Investigator: Saad AK Amer, MD University of Sheffield
  More Information

No publications provided by Sheffield Teaching Hospitals NHS Foundation Trust

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 06, 2009