PCOS Clinical Trial - Unilateral Laparoscopic Diathermy Adjusted to

Status Completed

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

PCOS

Clinical Trial Details

NCT number	NCT01833949
Study type	Interventional
Source	KBC Split
Contact
Status	Completed
Phase	N/A
Start date	September 2009
Completion date	January 2013

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms