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

NCT00220545 | Completed

• 1 other identifier: STH5735 01/173
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovarY; Laparoscopic ovarian diathermy; Induction of ovulation; Clomiphene citrate

Outcome Measures

Primary Outcomes (1)

• Pregnancy rates

Secondary Outcomes (1)

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

Interventions

Laparoscopic ovarian diathermy PROCEDURE

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Inability to give informed consent
• Contraindication to CC
• Contraindication to general anaesthetic or laparoscopy

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2SF, United Kingdom

Location

Related Publications (1)

• Amer SA, Li TC, Metwally M, Emarh M, Ledger WL. Randomized controlled trial comparing laparoscopic ovarian diathermy with clomiphene citrate as a first-line method of ovulation induction in women with polycystic ovary syndrome. Hum Reprod. 2009 Jan;24(1):219-25. doi: 10.1093/humrep/den325. Epub 2008 Sep 14.

  PMID: 18794162 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Saad AK Amer, MD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2002
• Study Completion: March 1, 2006
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

GB (1)