1) Objectives: Because of unilateral laparoscopic ovarian is one of the main ways to induction of ovulation in patients with polycystic ovarian syndrome, this study investigated respond patients to the treatment method.
2) Design: For this study, patients with polycystic ovarian syndrome selected who didn’t respond to clomiphene citrate drug treatment.
3) Setting and conduct: Patients randomly were divided into two groups, treated with clomiphene citrate and patients undergoing laparoscopic ovarian. This study was done at alzahra hospital, Tabriz-Iran on 60 patients. At first, serum samples were obtained to measurement anti-mullerian hormone assay then, 1 week, 1 and 3 months after the treatment protocol the measurement were performed. The patients response to treatment method was evaluated.
4) Participants including major eligibility criteria: Inclusion criteria include patients with polycystic ovary syndrome; PCOS patients resistance to drug clomiphene citrate; patients with symptoms of amenorrhea and exclusion criteria include patients with symptoms of oligomenorrhe; patients who were outside the age range.
5) Intervention: Intervention group include unilateral ovarian laparoscopic treatment in patients with polycystic ovary syndrome who resistant to drug treatment with a daily dose of 250 mg clomiphene citrate. Control group include clomiphene citrate administration with dose of 250 mg daily for 6 months in patients with polycystic ovary syndrome.
6) Main outcome measures: Serum anti-mullerian levels.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020420374N2
Registration date:2015-03-23, 1394/01/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-23, 1394/01/03
Registrant information
Name
Esmat Aghadavod
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
aghadavod@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tabriz University of medical Sciences
Expected recruitment start date
2009-03-20, 1387/12/30
Expected recruitment end date
2009-10-22, 1388/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Anti-Mullerian Hormone levels after laparoscopic treatment in women with anovulatory polycystic ovary syndrome
Public title
Anti-Mullerian Hormone levels after laparoscopic treatment in women with anovulatory polycystic ovary syndrome
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome; PCOS patients resistance to drug clomiphene citrate; patients with symptoms of amenorrhea. Exclusion criteria: Patients with symptoms of oligomenorrhea; patients who were outside the age range.
Age
From 25 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committes of Tabrz university of medical sciences
Street address
Medical faculty, Tabriz University of Medical Sciences , Daneshgah Blv, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2009-06-06, 1388/03/16
Ethics committee reference number
5/4/2353
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Sclerocystic ovary syndrome
Primary outcomes
1
Description
Serum anti-mullerian levels
Timepoint
Pre-treatment and 1 week, 1 and 3 month after treatment
Method of measurement
Serum anti-mullerian hormon levels on nanomoles per mml
Secondary outcomes
1
Description
Ovarian response to treatment method
Timepoint
1 and 3 month
Method of measurement
The first menstural cycle after treatment
Intervention groups
1
Description
Unilateral ovarian laparoscopic treatment in patients with polycystic ovary syndrome who resistant to drug treatment with a daily dose of 250 mg clomiphene citrate
Category
Treatment - Surgery
2
Description
The control group was clomiphene citrate administration with dose of 250 mg daily for 6 months in patients with polycystic ovary syndrome