Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume

NCT ID: NCT01833949

Last Updated: 2013-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-01-31

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

Conditions

PCOS

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ULOD arm (N=49)

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.

Group Type: ACTIVE_COMPARATOR

Unilateral laparoscopic drilling

Intervention Type: PROCEDURE

Unilateral laparoscopic drilling with diathermy adjusted to ovarian volume

BLOD arm (N=47)

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.

Group Type: ACTIVE_COMPARATOR

Bilateral laparoscopic drilling

Intervention Type: PROCEDURE

Bilateral laparoscopic drilling with fixed doses energy

Interventions

Unilateral laparoscopic drilling

Unilateral laparoscopic drilling with diathermy adjusted to ovarian volume

Intervention Type: PROCEDURE

Bilateral laparoscopic drilling

Bilateral laparoscopic drilling with fixed doses energy

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

KBC Split

OTHER

Sponsor Role: lead

Responsible Party

Martina Šunj

dr.med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martina MS Šunj, dr.med

Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Hospital Center Split

Split, Dalmatia, Croatia

Countries

Croatia

References

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.

Reference Type: DERIVED

PMID: 24965999 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23820423 (View on PubMed)

Other Identifiers

KBC-2013-HR

Identifier Type: -

Identifier Source: org_study_id