An interventional study of Unilateral laparoscopic drilling and Bilateral laparoscopic drilling in PCOS, sponsored by KBC Split. Completed at 1 site in Croatia. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2013-04-17.
Sponsored by KBC Split · Not applicable, Interventional, and Treatment
The objective of our study was to compare the efficiency of the right ULOD using thermal doses adjusted to ovarian volume (60 J/cm3) with the BLOD method at constant dose and to assess treatment efficiency.
The study included 96 infertile, clomiphene citrate-resistant women with polycystic ovary syndrome (PCOS), who underwent either unilateral or bilateral laparoscopic diathermy at the Clinical Hospital Split, Croatia. PCOS was diagnosed following the Rotterdam consensus criteria. In the ULOD group, we treated the right ovary with thermal dose of 60 J applied per one cubic centimeter of ovarian. In the comparator, BLOD group, all patients received 600 J per ovary. The follow-up period encompassed six menstrual cycles for all subjects.Sample size was based on the test of the primary hypothesis that ULOD treatment would result in a higher ovulation rate than BLOD. In our pilot study in 61 patients, ovulation rates were estimated to 44% in the BLOD arm and 69% in the ULOD arm. Assuming 5% significance and 80% power, we calculated that the minimal sample size for a one-sided test had to be 96 patients.
The aims of our prospective study:
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 96 is above the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
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PCOS was diagnosed following the Rotterdam consensus criteria
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Unilateral laparoscopic drilling In the ULOD group, we treated the right ovary.The thermal dose of 60 J applied per one cubic centimeter of ovarian volume was calculated from the mean total energy applied on a 10 cm3 ovary (627 J) from three earlier ULOD reports. Ovarian volume had been measured by ultrasound at baseline to determine the total thermal dose to apply on the right ovary. The number of punctures (Np) was also calculated for each patient according to the following formula: Np = 627 J / 30 W / 4 s Therefore, patients in the ULOD group differed in the number of punctures and energy received by the right ovary, depending on its volume.
Procedure: Unilateral laparoscopic drilling
Bilateral laparoscopic drilling In the comparator, BLOD group, all patients received 600 J per ovary (totaling 1200 J) through five punctures at 30 W for 4 s each (5 punctures x 4 s x 30 W = 600 J). The ovaries in both groups were cooled after the drilling by irrigating the abdominal cavity with 200-300 mL of physiological saline.
Procedure: Bilateral laparoscopic drilling
Unilateral laparoscopic drilling with diathermy adjusted to ovarian volume
Bilateral laparoscopic drilling with fixed doses energy
Ovulation rate
The main output parameter study is the difference in the rate of ovulation after LOD between the groups with respect to the input parameters (anti-Müller hormone AMH \[ng / ml\], free androgen index (FAI), T \[nmol / L\],luteinizing hormone (LH) \[IU / L\], androstenedione A \[nmol / L\], the number of follicles in both ovaries (AFC), total ovarian volume \[cm3\], the volume of the right ovary \[cm3\], the volume of the left ovary \[cm3\] and received thermal doses)
Time frame: Six menstrual cycles after LOD for each women
Pregnancy
The secondary output parameter is the difference in the probability of pregnancy between the two groups, with the input parameters (AFC, total ovarian volume \[cm3\], the volume of the right ovary \[cm3\], the volume of the left ovary \[cm3\] and received thermal doses), during follow-up of patients (first and sixth cycle after LOD).
Time frame: Six menstrual cycles after LOD for each women
Ovarian reserve
The secondary outcome measures were: correlations and differences in values (and changes) measured markers (unilateral / bilateral or ovulation / anovulation). Markers that are considered: AMH \[ng / ml\], follicle stimulating hormone (FSH) \[IU / L\], the number of follicles in both ovaries, total ovarian volume \[cm3\], the volume of the right ovary \[cm3\], the volume of the left ovary \[cm3\], FAI, T \[nmol / L\], LH \[IU / L\], A \[nmol / L\], sex hormone-binding globulin (SHBG) \[nmol / L\], dehydroepiandrosterone sulfate (DEHASO4), \[mmol / L\],prolactin (PRL), BMI \[kg/m2\] and years.
Time frame: Six menstrual cycles after LOD for each women
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