Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 |
Eligibility| Ages Eligible for Study: | 19 Years to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust | |
| Sheffield, South Yorkshire, United Kingdom, S10 2SF | |
| 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 ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00220545 History of Changes |
| Other Study ID Numbers: | 01/173 |
| Study First Received: | September 14, 2005 |
| Last Updated: | October 22, 2007 |
| 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 |
Additional relevant MeSH terms:
|
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Clomiphene Estrogen Antagonists |
Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Fertility Agents, Female Fertility Agents Reproductive Control Agents Therapeutic Uses Selective Estrogen Receptor Modulators |
ClinicalTrials.gov processed this record on May 22, 2013