Objective: To evaluate the effect of N-acetyl-cysteine (NAC), a mucolytic drug with insulin sensitizing properties, as an adjuvant therapy to letrozole in infertile women with polycystic ovarian syndrome (PCOS)
Design: randomized clinical trial.
Patients: forty infertile women diagnosed with PCOS, with normal TSH and prolactin, normal hysterosalpingographies, and normal spermograms of partners.
Interventions: The patients are assigned randomly to receive either letrozole 5 mg/d (group I) or letrozole 5 mg/d and NAC 1.2 g/d (group II) for 5 days starting at day 3 of the cycle. On 14th day of cycle, transvaginal ultrasonography will be performed to evaluate endometrial thickness and follicles properties. If mature follicle (18 mm or larger) detected, hCG will be injected and timed coitus advised 12, 36, and 60 hours later. β-hCG level is checked on day 16 after hCG injection.
Outcome measures: ovulation rate, pregnancy rate, and endometrial thickness in each group
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050617593N1
Registration date:2015-06-16, 1394/03/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-16, 1394/03/26
Registrant information
Name
Fatemeh Mohebbi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
fmohebbi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences (QUMS)
Expected recruitment start date
2014-12-31, 1393/10/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
N-acetylcysteine as an adjuvant to letrozole for induction of ovulation in infertile women with polycystic ovarian syndrome
Public title
N-acetylcysteine in treatment of infertile women with polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: infertile women with PCOS (according to ESHRE/ASRM criteria) with normal hysterosalpingographies, normal spermograms of partners, and not impaired sexual functions
exclusion criteria: ovarian cyst >6 cm, history of asthma or allergy, consumption of any drugs with effects on glucose metabolism during the last 3 months before entering the trial.
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Blv., Qazvin
City
Qazvin
Postal code
Approval date
2014-12-06, 1393/09/15
Ethics committee reference number
28/20/9537
Health conditions studied
1
Description of health condition studied
infertility in polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
polycystic ovarian syndrome
2
Description of health condition studied
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
ovulation rate
Timepoint
7 days after intervention (14th day of menstrual cycle)
Method of measurement
detecting at least one 18 mm follicle or larger in vaginal ultrasonography
2
Description
pregnancy rate
Timepoint
23 days after intervention (30th day of menstrual cycle)
Method of measurement
laboratory measurement of hCG-ß level
Secondary outcomes
1
Description
endometrial thickness
Timepoint
7 days after intervention (14th day of menstrual cycle)
Method of measurement
measuring endometrial thickness by means of vaginal ultrasonography (millimeters)
Intervention groups
1
Description
letrozole 2.5 mg oral tablets twice daily, for 5 days starting on day 3 of the menstrual cycle
Category
Treatment - Drugs
2
Description
letrozole 2.5 mg oral tablets twice daily, plus N-acetyl cysteine 600 mg oral tablets twice daily, for 5 days starting on day 3 of the menstrual cycle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Dabbaghi's outpatient office
Full name of responsible person
Dr Fatemeh Mohebbi
Street address
Azadi Doctors Building, Azadi Sqr., Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ms. Shamekhi
Street address
Qazvin University of Medical Sciences, Bahonar Blv., Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
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
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Mohebbi
Position
OB/GYN Resident
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Blv., Qazvin
City
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 9252
Fax
Email
info@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Mohebbi
Position
OB/GYN Resident
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Blv., Qazvin
City
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 9252
Fax
Email
info@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences, Bahonar Blv., Qazvin
Full name of responsible person
Dr Fatemeh Mohebbi
Position
OB/GYN Resident
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Blv., Qazvin
City
Qazvin
Postal code
34197-59811
Phone
+98 283336001
Fax
Email
fmohebbi@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)