Clinical trial NCT01833949: Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCOS
Keywords: polycystic ovary syndrome,laparoscopic ovarian drilling
Lead sponsor: KBC Split
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 96
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Ovulation rate
timeFrame: Six menstrual cycles after LOD for each women
Secondary outcomes:
measure: Pregnancy
timeFrame: Six menstrual cycles after LOD for each women
Other outcomes:
measure: Ovarian reserve
timeFrame: Six menstrual cycles after LOD for each women
Locations:
city: Split
country: Croatia
facility: Clinical Hospital Center Split
state: Dalmatia
Study officials:
name: Martina MS Šunj, dr.med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sunj M, Canic T, Jeroncic A, Karelovic D, Tandara M, Juric S, Palada I. Anti-Mullerian hormone, testosterone and free androgen index following the dose-adjusted unilateral diathermy in women with polycystic ovary syndrome. Eur J Obstet Gynecol Reprod Biol. 2014 Aug;179:163-9. doi: 10.1016/j.ejogrb.2014.05.011. Epub 2014 Jun 2.
citation: Sunj M, Canic T, Baldani DP, Tandara M, Jeroncic A, Palada I. Does unilateral laparoscopic diathermy adjusted to ovarian volume increase the chances of ovulation in women with polycystic ovary syndrome? Hum Reprod. 2013 Sep;28(9):2417-24. doi: 10.1093/humrep/det273. Epub 2013 Jul 2.