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Comparison of ovulation rate in unilateral and bilateral ovarian electrocautery in infertile women with Clomiphene citrate resistant polycystic ovarian syndrome

Protocol summary

Summary
The aim of this study is to compare unilateral and bilateral ovarian drilling in terms of menstrual cycle, hormonal profile after surgery ovulation and pregnancy rate in patients with polycystic ovarian syndrome. The inclusion criteria: age: 20-38, BMI<32, infertile women with disorders of ovulation for more than 1 year, normal semen analysis in partner, normal HSG, resistance to Clomiphene citrate, absence of any major disease. The exclusion criteria: Other cause of infertility, use of other indicated ovulation diets, like Metformin, any abnormalities of fallopian tubes, endometriosis during laparoscopy. All unovalatory patients with Clomiphene citrate resistant polycystic ovarian syndrome that visit in infertility clinic between July 2010 to July 2011 will be studied if they candidate for ovarian drilling by infertility fellowship. Patients will be assessed by transvaginal sonography and hormonal profile (FSH, LH, testosterone in third day of menstrual cycle) before study. Hundred patients will randomly allocate to either unilateral or bilateral ovarian drilling. The ovulation rate, hormonal level and rate of pregnancy will be compared in two groups during 6-month follow up.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903291306N2
Registration date: 2010-10-03, 1389/07/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-10-03, 1389/07/11
Registrant information
Name
Ziba Zahiri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
drzibazahiri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research – Guilan university of medical sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison of ovulation rate in unilateral and bilateral ovarian electrocautery in infertile women with Clomiphene citrate resistant polycystic ovarian syndrome
Public title
Comparison of ovulation rate after Laparoscopic electrocautery in infertile women with Clomiphene citrate resistant polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age: 20-38, BMI<32, infertile women with polycystic ovarian syndrome and infertility duration more than 1 year caused by disorder of ovulation, normal semen analysis in partner, normal hystrosalpangography, rsistance to Clomiphene citrate, absence of any major disease. Exclusion criteria: Other cause of infertility, use of other indicated ovulation diets like Metformin, any abnormalities of fallopian tubes and endometriosis during laparoscopy.
Age
From 20 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Reasearch vice chancellorship_Guilan University of Medical Sciences
Street address
Namjo street
City
Rasht
Postal code
Approval date
2010-07-15, 1389/04/24
Ethics committee reference number
1694

Health conditions studied

1

Description of health condition studied
Female infertility associated with anovulation
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
ovulation rate
Timepoint
every month up to 6 months
Method of measurement
Observing ovulation signs in serial transvaginal sonography and measuring progesterone level at 21th day of menstrual cycle

Secondary outcomes

1

Description
serum hormonal level (FSH, LH, testosterone)
Timepoint
Third day of first menstrual cycle after laparoscopy
Method of measurement
According to FSH, LH (mIU/ml) and testosterone (nmol/ml)

2

Description
Clomiphene citrate dose for induction ovulation (If ovulation spontaneously don’t return)
Timepoint
6 weeks and 10 weeks after laparoscopy
Method of measurement
Amount of Clomiphen citrate (mg) needed for ovolation

3

Description
pregnancy rate
Timepoint
during 6 month after laparoscopy
Method of measurement
Observing gestational sac in transvaginal sonography and positive serumal BhCG

Intervention groups

1

Description
Laparoscopic unilateral ovarian cauterization
Category
Treatment - Surgery

2

Description
Laparoscopic bilateral ovarian cauterization
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Reproduction health researcher center, Alzahra hospital
Full name of responsible person
Street address
Namjo street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research vice chancellorship-Guilan university of Medical Science
Full name of responsible person
Dr.Abdolrasol Sobhani
Street address
Namjo street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice chancellorship-Guilan university of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Ziba Zahiri
Position
Associated professor
Other areas of specialty/work
Street address
Reporoduction Health researcher center , Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
drzibazahiri@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Seyedeh Maryam Mousavi
Position
Other areas of specialty/work
Street address
Reproduction Health, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
empty
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