Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume

Not Applicable

Completed

• Conditions: PCOS
• Interventions: Procedure: Unilateral laparoscopic drilling; Procedure: Bilateral laparoscopic drilling

• Registration Number: NCT01833949
• Lead Sponsor: KBC Split

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2009-09
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-04
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-13
• Last Update Submitted: 2013-04-13
• Study First Posted: 2013-04-17
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• age between 25 and 35 years,
• BMI<30 kg/m2,
• infertility period 1-3 years,
• normal partner's semen findings,
• LH≥10 or LH:FSH ratio ≥2,
• testosterone >2.5 nmol/L,
• FAI>4,
• normal oral glucose tolerance test (OGTT).

Exclusion Criteria

• adrenal hyperplasia,
• thyroid disease,
• Cushing's syndrome,
• hyperprolactinemia,
• tumor-related androgen excess

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ULOD arm (N=49)	Unilateral laparoscopic drilling	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.
BLOD arm (N=47)	Bilateral 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.

Primary Outcome Measures

Name	Time	Method
Ovulation rate	Six menstrual cycles after LOD for each women	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)

Secondary Outcome Measures

Name	Time	Method
Pregnancy	Six menstrual cycles after LOD for each women	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).

Trial Locations

Locations (1)

Clinical Hospital Center Split; 🇭🇷 Split, Dalmatia, Croatia