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: 1. 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 and predict ovulatory response based on clinical parameters (right or left ovary and its volume) and received thermal doses. 2. Evidence the effects of ULOD using thermal doses adjusted to ovarian volume on endocrine (changes in androgen and AMH) and reproductive outcomes (ovulation rate) in clomiphene-resistant women with PCOS. 3. To determine whether unilateral laparoscopic ovarian drilling (ULOD) using thermal doses adjusted to ovarian volume diminishes ovarian reserve less than bilateral LOD (BLOD) using a fixed thermal dose
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Unilateral laparoscopic drilling with diathermy adjusted to ovarian volume
Bilateral laparoscopic drilling with fixed doses energy
Clinical Hospital Center Split
Split, Dalmatia, Croatia
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
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