To compare the success rate of standard method vs dose-dependent ovarian electrocautery in in patients with Polycystic ovary syndrome
Design
In this study, 60 women with polycystic ovary syndrome who had the inclusion criteria and were interested to participate in the study, were randomly divided into two groups: the standard ovarian electrocautery group and the dose-dependent ovarian electrocautery group . The allocation of patients to groups will be based on a random number table.
Settings and conduct
Imam Reza Hospital, Mashhad
The patients are blind about their surgery type.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age: 18-38;
Infertile women (duration more than 2 year) with polycystic ovarian syndrome;
Cause of infertility: disorder of ovulation;
Normal semen analysis in partner;
Normal hystrosalpangography and laparoscopy;
Interested for participation;
Resistance to Clomiphene citrate.
Exclusion criteria:
Other cause of infertility.
Intervention groups
dose-dependent ovarian electrocautery in patients with polycystic ovary syndrome (As intervention group) ,
Standard ovarian electrocautery in patients with polycystic ovary syndrome (As control group)
Main outcome variables
Ovulation rate or pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171210037820N1
Registration date:2018-01-02, 1396/10/12
Registration timing:registered_while_recruiting
Last update:2018-01-02, 1396/10/12
Update count:0
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
Ghazal Ghasemi Torshizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3223 1444
Email address
ghasemitg931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the success rate of standard method vs dose-dependent ovarian electrocautery in patients with Polycystic ovary syndrome
Public title
Comparison between the success rate of standard method vs dose-dependent ovarian electrocautery in polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18-38, Infertile women (duration more than 2 year)
with polycystic ovarian syndrome
cause of infertility: disorder of ovulation
Normal semen analysis in partner
Normal hystrosalpangography and laparoscopy
Interested for participation
Resistance to Clomiphene citrate
Exclusion criteria:
Other cause of infertility
Age
From 18 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients are blind about their surgery type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qoreishi Building, Daneshgah Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2016-10-26, 1395/08/05
Ethics committee reference number
IR.MUMS.fm.REC.1395.335
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Ovulation rate or pregnancy
Timepoint
every month up to 6 months
Method of measurement
Observing ovulation signs in serial transvaginal sonography or pregnancy
2
Description
Measuring progesterone level at 21th day of menstrual cycle
Timepoint
21th day of first menstrual cycle after surgery
Method of measurement
According to level (ng/ml) / ELISA (Enzyme-linked immunosorbent assay) method
3
Description
LH, testosterone, and DHEAS serum level
Timepoint
Third day of first menstrual cycle after surgery
Method of measurement
According to LH (IU/ml) and testosterone (ng/dl) and DHEAS (µg/dl) level / ELISA (Enzyme-linked immunosorbent assay) method