Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS
Information source: Sheffield Teaching Hospitals NHS Foundation Trust
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome
Intervention: Laparoscopic ovarian diathermy (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Sheffield Teaching Hospitals NHS Foundation Trust Official(s) and/or principal investigator(s):
Saad AK Amer, MD, Principal Investigator, Affiliation: University of Sheffield
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Pregnancy rates
Secondary outcome: Ovulation, Pregnancy outcome (especially miscarriage), Menstrual pattern, Endocrine changes, Side effects / complications rate
Eligibility
Minimum age: 19 Years.
Maximum age: 39 Years.
Gender(s): Female.
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
Locations and Contacts
Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, South Yorkshire S10 2SF, United Kingdom
Additional Information
Starting date: March 2002
Ending date: March 2006
Last updated: October 22, 2007
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