Ignite Creation Date:
2024-05-06 @ 1:33 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01833949
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2013-04-10
Brief Title:
Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume
Sponsor:
KBC Split
Organization:
KBC Split
Study Overview
Official Title:
This Prospective Longitudinal Cohort Study Included Infertile Women With PCOS Unresponsive to Clomiphene Citrate Treatment Who Underwent Either Unilateral ULOD or Bilateral BLODLaparoscopic Diathermy
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of our study was to compare the efficiency of the right ULOD using thermal doses adjusted to ovarian volume 60 Jcm3 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 subjectsSample 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 Jcm3 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
The aims of our prospective study
1 Compare the efficiency of the right ULOD using thermal doses adjusted to ovarian volume 60 Jcm3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None