Contact information
Type
Scientific
Primary contact
Prof Bill Ledger
ORCID ID
Contact details
University of Sheffield
OGN & Midwifery
Jessop Wing
Sheffield
S10 2SF
United Kingdom
+44 (0)114 226 8317
w.ledger@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00220545
Protocol/serial number
N0059108266
Study information
Scientific title
Acronym
Study hypothesis
Laparoscopic ovarian diathermy (LOD) is currently widely used as an effective second line treatment for induction of ovulation in anovular infertile women with polycyctic ovarian syndrome (PCOS) after failure of a course of clomiphene citrate (CC). CC treatment is associated with significant drawbacks including a lower than expected pregnancy rate, high miscarriage rate (about 40%) and increased incidence of multiple pregnancies (10%). These well-documented drawbacks to CC create equipoise between CC and LOD. The aim of this study is to test the hypothesis that LOD used as a first line treatment in these cases will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than treatment with clomiphene citrate.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Polycystic ovarian syndrome (PCOS)
Intervention
Compare laparoscopic ovarian diathermy with clomiphene citrate as a first line treatment.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Live birth rate
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2001
Overall trial end date
01/09/2004
Reason abandoned
Eligibility
Participant inclusion criteria
264 infertile women with PCOS
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
264
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/10/2001
Recruitment end date
01/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Sheffield
Sheffield
S10 2SF
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
UK charity
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18794162
2. 2009 results on anti-Mullerian hormone measurement in http://www.ncbi.nlm.nih.gov/pubmed/19640893
Publication citations
-
Results
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, 24, 1, 219-225, doi: 10.1093/humrep/den325.
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Amer SA, Li TC, Ledger WL, The value of measuring anti-Mullerian hormone in women with anovulatory polycystic ovary syndrome undergoing laparoscopic ovarian diathermy., Hum. Reprod., 2009, 24, 11, 2760-2766, doi: 10.1093/humrep/dep271.