Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
12/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes