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Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume

Primary Purpose

PCOS

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Unilateral laparoscopic drilling
Bilateral laparoscopic drilling
Sponsored by
KBC Split
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS focused on measuring polycystic ovary syndrome,laparoscopic ovarian drilling

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Hospital Center Split

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ULOD arm (N=49)

BLOD arm (N=47)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).

Full Information

First Posted
April 10, 2013
Last Updated
April 13, 2013
Sponsor
KBC Split
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1. Study Identification

Unique Protocol Identification Number
NCT01833949
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KBC Split

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS
Keywords
polycystic ovary syndrome,laparoscopic ovarian drilling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ULOD arm (N=49)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BLOD arm (N=47)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Unilateral laparoscopic drilling
Intervention Description
Unilateral laparoscopic drilling with diathermy adjusted to ovarian volume
Intervention Type
Procedure
Intervention Name(s)
Bilateral laparoscopic drilling
Intervention Description
Bilateral laparoscopic drilling with fixed doses energy
Primary Outcome Measure Information:
Title
Ovulation rate
Description
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)
Time Frame
Six menstrual cycles after LOD for each women
Secondary Outcome Measure Information:
Title
Pregnancy
Description
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).
Time Frame
Six menstrual cycles after LOD for each women
Other Pre-specified Outcome Measures:
Title
Ovarian reserve
Description
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.
Time Frame
Six menstrual cycles after LOD for each women

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martina MS Šunj, dr.med
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Hospital Center Split
City
Split
State/Province
Dalmatia
ZIP/Postal Code
21000
Country
Croatia

12. IPD Sharing Statement

Citations:
PubMed Identifier
24965999
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.
Results Reference
derived
PubMed Identifier
23820423
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.
Results Reference
derived

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Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume

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