A prospective randomised controlled trial to compare laparoscopic ovarian diathermy with clomiphene citrate as a first line treatment of anovulatory infertiliity in patients with polycystic ovarian syndrome

ISRCTN ISRCTN54264327
DOI https://doi.org/10.1186/ISRCTN54264327
ClinicalTrials.gov number NCT00220545
Secondary identifying numbers N0059108266
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
12/09/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Bill Ledger
Scientific

University of Sheffield
OGN & Midwifery
Jessop Wing
Sheffield
S10 2SF
United Kingdom

Phone +44 (0)114 226 8317
Email w.ledger@sheffield.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesLaparoscopic 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPolycystic ovarian syndrome (PCOS)
InterventionCompare laparoscopic ovarian diathermy with clomiphene citrate as a first line treatment.
Intervention typeOther
Primary outcome measureLive birth rate
Secondary outcome measuresNot provided at time of registration
Overall study start date01/10/2001
Completion date01/09/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants264
Key inclusion criteria264 infertile women with PCOS
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/10/2001
Date of final enrolment01/09/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Sheffield
Sheffield
S10 2SF
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Charity

UK charity

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2009 Yes No
Results article results on anti-Mullerian hormone measurement 01/11/2009 Yes No