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 (NCT) | NCT00220545 |
| Protocol serial number | N0059108266 |
| Sponsor | Department of Health (UK) |
| Funder | UK charity |
- 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
Scientific
University of Sheffield
OGN & Midwifery
Jessop Wing
Sheffield
S10 2SF
United Kingdom
| Phone | +44 (0)114 226 8317 |
|---|---|
| w.ledger@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Polycystic ovarian syndrome (PCOS) |
| Intervention | Compare laparoscopic ovarian diathermy with clomiphene citrate as a first line treatment. |
| Intervention type | Other |
| Primary outcome measure(s) |
Live birth rate |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 264 |
| Key inclusion criteria | 264 infertile women with PCOS |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 01/09/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Sheffield
Sheffield
S10 2SF
United Kingdom
S10 2SF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
