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Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00220545
Enrollment
72
Registered
2005-09-22
Start date
2002-03-31
Completion date
2006-03-31
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovarY, Laparoscopic ovarian diathermy, Induction of ovulation, Clomiphene citrate

Brief 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.

Interventions

PROCEDURELaparoscopic ovarian diathermy

Sponsors

University of Sheffield
CollaboratorOTHER
Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 39 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pregnancy rates

Secondary

MeasureTime frame
Ovulation, Pregnancy outcome (especially miscarriage), Menstrual pattern, Endocrine changes, Side effects / complications rate

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026