Comparison of the effects of letrozole with letrozole in combination with clomiphene on ovulation and pregnancy rate in infertile patients with polycystic ovarian syndrom under Ovulation induction
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Recruitment centers
#1
Name of recruitment center - English: Infertility center,Imam Khomeini Hospital
Name of recruitment center - Persian: مرکز ناباروری،بیمارستان امام خمینی،
Full name of responsible person - English: Marzieh Zamanian
Full name of responsible person - Persian: مرضیه زمانیان
Street address - English: 233 plaque,ground floor,IVF ward,Imam Khomeini Hospital,Amirmazandarani Ave,sari
Street address - Persian: ساری،خیابان امیر مازندرانی،بیمارستان امام خمینی،طبقه همکف،بخش ای وی اف ، پلاک ۲۳۳
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 5494483
Phone: +98 11 3336 5724
Fax:
Email: Marziehzamanian@gmail.com
Web page address:
Name of recruitment center - English: Infertility center,Imam Khomeini Hospital
Name of recruitment center - Persian: مرکز ناباروری، بیمارستان امام خمینی
Full name of responsible person - English: Marzieh Zamanian
Full name of responsible person - Persian: مرضیه زمانیان
Street address - English: ground floor, IVF ward, NO 233, Imam Khomeini Hospital, Amirmazandarani Ave
Street address - Persian: خیابان امیر مازندرانی، بیمارستان امام خمینی،طبقه همکف، بخش ای وی اف ، پلاک ۲۳۳
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 5494483
Phone: +98 11 3336 5724
Fax:
Email: Marziehzamanian@gmail.com
Web page address:
Name of recruitment center - English: Infertility center,Imam Khomeini Hospital Name of recruitment center - Persian: مرکز ناباروری،بیمارستان امام خمینی، Full name of responsible person - English: Marzieh Zamanian Full name of responsible person - Persian: مرضیه زمانیان Street address - English: ground floor, IVF ward, NO 233 plaque,ground floor,IVF ward,Imam, Imam Khomeini Hospital,Amirmazandarani Ave,sariHospital, Amirmazandarani Ave Street address - Persian: ساری،خیابان امیر مازندرانی،بیمارستان امام خمینی،طبقه همکف،بخش ای وی اف ، پلاک ۲۳۳ City - English: Sari City - Persian: ساری Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: 5494483 Phone: +98 11 3336 5724 Fax: Email: Marziehzamanian@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Marzieh Zamanian
Full name of responsible person - Persian: مرضیه زمانیان
Street address - English: 242 plaqe,third floor,mazandaran Univercity of medical Sience,Joybar street,sari.
Street address - Persian: ساری،خیابان جویبار،دانشگاه علوم پزشکی مازندران،طبقه سوم،پلاک۲۴۲
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 98762345
Phone: +98 11 3336 5724
Fax:
Email: m.zamanian@mazums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Marzieh Zamanian
Full name of responsible person - Persian: مرضیه زمانیان
Street address - English: Third floor, NO 242, Mazandaran University of Medical Sciences, Joybar street
Street address - Persian: خیابان جویبار،دانشگاه علوم پزشکی مازندران،طبقه سوم،پلاک۲۴۲
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 98762345
Phone: +98 11 3336 5724
Fax:
Email: m.zamanian@mazums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Marzieh Zamanian Full name of responsible person - Persian: مرضیه زمانیان Street address - English: Third floor, NO 242 plaqe,third floor,mazandaran Univercity, Mazandaran University of medical Sience,Joybar street,sari.Medical Sciences, Joybar street Street address - Persian: ساری،خیابان جویبار،دانشگاه علوم پزشکی مازندران،طبقه سوم،پلاک۲۴۲ City - English: Sari City - Persian: ساری Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: 98762345 Phone: +98 11 3336 5724 Fax: Email: m.zamanian@mazums.ac.ir Web page address:
Sari University of Medical Sciences
Mazandaran University of Medical Sciences
SariMazandaran University of Medical Sciences
دانشگاه علوم پزشکی ساری
دانشگاه علوم پزشکی مازندران
دانشگاه علوم پزشکی ساریمازندران
Protocol summary
Study aim
Comparison the effect of letrozole and clomiphene citrate plus letrozole on the pregnancy rate among infertile patients with polycystic ovarian syndrome undergoing induction of ovulation
Design
Not blind randomized controlled clinical trial with two parallel groups
Settings and conduct
The study place: Infertility Center, Imam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female aged 35 or lower, mild male factor infertility, Poly cyctic ovarian syndrome
Exclusion criteria: Reluctance to participate in study, body mass index above 27, endocrine disorder including Hypothyroidism, hyperprolactinemia, diminished ovarian reserve
Intervention groups
First intervention group: Letrozole (2.5 mg tablet, Iranian hormones Company) is given twice daily from the third to seventh day of the menstrual cycle.
Second intervention group: Clomiphene 2 tablets daily (50 mg tablets, Iran hormones) and Letrozole (2.5 mg tablets, Iran Hormones Company) oral،twice daily fromf the third to seventh day of the menstrual cycle.
Main outcome variables
Pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160815029374N6
Registration date:2019-05-24, 1398/03/03
Registration timing:registered_while_recruiting
Last update:2023-06-24, 1402/04/03
Update count:1
Registration date
2019-05-24, 1398/03/03
Registrant information
Name
Marzieh Zamaniyan
Name of organization / entity
Mazandaran University of Medical Sciences, Sari, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 5724
Email address
m.zamanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of letrozole with letrozole in combination with clomiphene on ovulation and pregnancy rate in infertile patients with polycystic ovarian syndrom under Ovulation induction
Public title
Effects of letrozole in combination with clomiphene on infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female aged 35 or lower
Mild male factor infertility
Poly cyctic ovarian syndrome
Exclusion criteria:
Reluctance to participate in study
Body mass index above 27
Endocrine disorder including Hypothyroidism, hyperprolactinemia
Diminished ovarian reserve
History of pelvic surgery
History of ovarian hyperstimulation syndrome
Severe male factor infertility
Abnormal hysterosalpingography
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
194
Randomization (investigator's opinion)
Randomized
Randomization description
In the first phase of sampling, after applying the criteria for entry and exclude, samples are selected in an accessible manner. Individuals with the criteria for entering, informed consent are obtained. Then, in the second phase, the samples will be assigned to two groups by blocking method. Create blocks and generate random numbers with Random allocation soft ware. The thirty-two blocks of size six will be produced and arranged by the project manager.
Blinding (investigator's opinion)
Single blinded
Blinding description
The individuals implementing the intervention and evaluating the outcome will not be aware of the allocation of participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
No. 240,Ground Floor, Joibar Ave., Mazandaran University of Medical Sciences., Sari
City
Sari
Province
Mazandaran
Postal code
4815659769
Approval date
2019-03-06, 1397/12/15
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1398.001
Health conditions studied
1
Description of health condition studied
Disease of genitourinary tract
ICD-10 code
Female inf
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
Three weeks after positive B-HCG
Method of measurement
ultrasonography
2
Description
Ovulation rate
Timepoint
Forty-eight hours after HCG injection
Method of measurement
ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Letrozole (2.5 mg tablet, Iranian hormones Company) is given twice daily from the third to seventh day of the menstrual cycle.
Category
Treatment - Drugs
2
Description
Intervention group 2: Clomiphene 2 tablets daily (50 mg tablets, Iran hormones) and Letrozole (2.5 mg tablets, Iran Hormones Company) oral،twice daily from the third to seventh day of the menstrual cycle.