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NCT Number: NCT01833949

Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume

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.

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Key information

Conditions

PCOS Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital Center Split

Split, Dalmatia, 21000, Croatia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unilateral laparoscopic drilling

Procedure

Unilateral laparoscopic drilling with diathermy adjusted to ovarian volume

Bilateral laparoscopic drilling

Procedure

Bilateral laparoscopic drilling with fixed doses energy

Primary outcomes

  1. Ovulation rate

    Time frame: Six menstrual cycles after LOD for each women

    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 outcomes

  1. Pregnancy

    Time frame: Six menstrual cycles after LOD for each women

    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).

Other outcomes

  1. Ovarian reserve

    Time frame: Six menstrual cycles after LOD for each women

    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.

Sponsors and collaborators

Lead sponsor

KBC Split

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 17, 2013
Registry last updated
Apr 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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