Polycystic Ovary Syndrome
Conditions
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
Sponsors
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| Pregnancy rates | — |
Secondary
| Measure | Time frame |
|---|---|
| Ovulation, Pregnancy outcome (especially miscarriage), Menstrual pattern, Endocrine changes, Side effects / complications rate | — |
Countries
United Kingdom