Comparison the efficacy of Letrozole-gonadotropins and clomiphene citrate-gonadotropins in Ovarian hyper stimulation of infertile women undergoing intra uterine insemination procedure
Patients with unovulation, poly cystic ovary syndrome were included and those with infertility of tubal factor, male factor and age over 35 in women will be excluded. Then 80 subjects will randomly allocated to groups A (Letrozole-gonadotropins) and B (clomiphene citrate-gonadotropins). The patients in the letrozole group (Group A) will receive 5 mg letrozole for 5 days from day 3 of their menstrual cycle. In the CC-gonadotropin group (Group B) clomiphene citrate 100 mg will be given for 5 days starting from day 3 of menstrual cycle. In addition, human menopausal gonadotropin 75 IU will be administered every day, starting on day 6 until human chorionic gonadotropin (hCG) administration. The condition of the ovaries would determined by transvaginal ultrasonography.
Sonography will perform every other day from day 10 of the cycle by a single radiologist. When mature leading follicle (s) reached>18 mm in diameter, IM hCG in a dose of 5000-10000 IU will be given and IUI will be performed 36–40 hours later.
The main outcome measurement is pregnancy rate. Clinical pregnancy was defined when an intrauterine gestational sac(s) was visible by ultrasonography
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106236868N1
Registration date:2011-07-20, 1390/04/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-20, 1390/04/29
Registrant information
Name
Mahzad Sadaghiani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
sadaghianim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Sciences and Health Services
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of Letrozole-gonadotropins and clomiphene citrate-gonadotropins in Ovarian hyper stimulation of infertile women undergoing intra uterine insemination procedure
Public title
Effect of letrozole on ovarian hyper stimulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: unovulation, poly cystic ovary syndrome
Exclusion criteria: ifertility with the tubal cause ( occlusion of one or both tubes), infertility with sever male cause (less than 10 milion motile sperm), intrauterine masses ( myoma and polyp), uterine endometrioma, age over 35 year of women
Age
From 15 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Tabriz university institutional ethics review board
Street address
Azadi avenue, Golgasht street, Vice Chancellor for Research, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2010-07-11, 1389/04/20
Ethics committee reference number
5/4/2762
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female Infertility
Primary outcomes
1
Description
first follicle generation
Timepoint
one dy another 7-9 days after period
Method of measurement
vaginl ultrasonography
Secondary outcomes
1
Description
pregnancy
Timepoint
18 days after IUI
Method of measurement
by BHCG
Intervention groups
1
Description
first group: letrozole-gonadotropin
patients in group letrozole (group A) will receive 5 mg letrozole for five days from day 3 of the menstrual cycle
Category
Treatment - Drugs
2
Description
Second group: clomiphen citrate - gonadotropin
In the CC-gonadotropin group (Group B) clomiphene citrate 100 mg will be given for 5 days starting from day 3 of menstrual cycle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Street address
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Mciences
Full name of responsible person
vice chancellor of research
Street address
Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Mciences
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
Tabriz University of Medical Sciences
Full name of responsible person
dr mahzad mehrzad sadaghiani
Position
associte proffesor
Other areas of specialty/work
Street address
Alzahra Hospital, bagh-shomal, Arteshe Jonoubi street
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
sadaghainim@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Mciences
Full name of responsible person
Dr mahzad Mehrzad Sadaghiani
Position
gynecologist, IVF fellowship
Other areas of specialty/work
Street address
Alzahra Hospital, bagh-shomal, Arteshe Jonoubi street
City
Tabriz
Postal code
Phone
+98 44 1556 6149
Fax
Email
sadaghianim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Mciences
Full name of responsible person
Dr mahzad mehrzad sadaghiani
Position
gynecologist, IVF fellowship
Other areas of specialty/work
Street address
Alzahra Hospital, bagh-shomal, Arteshe Jonoubi street
City
tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
sadaghianim@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)