Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume

PCOS Clinical Trial

Official title:

This Prospective Longitudinal Cohort Study Included Infertile Women With PCOS Unresponsive to Clomiphene Citrate Treatment, Who Underwent Either Unilateral (ULOD) or Bilateral (BLOD)Laparoscopic Diathermy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833949
• Other study ID #: KBC-2013-HR
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: April 13, 2013
• Start date: September 2009
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: KBC Split
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

PCOS was diagnosed following the Rotterdam consensus criteria

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PCOS

Intervention

Procedure:
• Unilateral laparoscopic drilling
Unilateral laparoscopic drilling with diathermy adjusted to ovarian volume
• Bilateral laparoscopic drilling
Bilateral laparoscopic drilling with fixed doses energy

Locations

Country	Name	City	State
Croatia	Clinical Hospital Center Split	Split	Dalmatia

Sponsors (1)

Lead Sponsor	Collaborator
KBC Split

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Six menstrual cycles after LOD for each women	No
Primary	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)	Six menstrual cycles after LOD for each women	No
Secondary	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).	Six menstrual cycles after LOD for each women	No