The aim of this study is the evaluation of the effect of clomiphen& tamoxifen in pregnancy rate. The inclusion criteria are infertile women with ovulatory dysfunction without any other causes. The exclusion criteria are: abnormal semen analysis and HSG or laparoscopy , age over 40, myoma, hyperprolactinema, FSH over12, hypothyroidism, hyperthyroidism, previous history of induction of ovulation, renal & liver disease and contraindication of clomiphen citrate and tamoxifen. The study population are 144 infertile women with ovulatory dysfunction who refered to infertility clinic of Alzahra hospital, after giving informed constant they randomized into two groups half of patients received tamoxifen 2 tab daily(40mg) for 5 day and the other half clomiphen 3 tab daily for 5 day from day 3-7 of menstrual cycle. Serial sonography for determination of endometrial thickness and pattern and number of dominant follicle was done. 5000 unit hcg after receiving at least one follicle ≥18mm injected and then the patients compared to gather from the points of pregnancy rate and side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206131306N3
Registration date:2012-07-10, 1391/04/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-10, 1391/04/20
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
Guilan University of Medical Sciences
Expected recruitment start date
2007-11-11, 1386/08/20
Expected recruitment end date
2008-11-10, 1387/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of clomiphene and tamoxifen on pregnancy rate in infertile women with anovulation
Public title
Effects of clomiphene and tamoxifen on pregnancy rate in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: infertile women with ovulation disorders without other cause of infertility. Exclusion criteria: abnormal semen analysis and HSG or laparoscopy; age over 40; myoma; hyperprolactinema; FSH over12; hypothyroidism; hyperthyroidism; previous history of induction of ovulation; renal & liver disease and contraindication of clomiphen citrate and tamoxifen.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
144
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Road Tehran, Faculty of Medicine
City
rasht
Postal code
Approval date
2007-11-11, 1386/08/20
Ethics committee reference number
443
Health conditions studied
1
Description of health condition studied
Ovarian dysfunction, unspecified
ICD-10 code
E28.9
ICD-10 code description
Ovarian dysfunction, unspecified
Primary outcomes
1
Description
Pregnancy rate
Timepoint
End of menstural cycle
Method of measurement
Serum BhCG
Secondary outcomes
1
Description
Abortion rate
Timepoint
End of menstrual cycle
Method of measurement
The incidence of menstrual bleeding and new
2
Description
Multigestation rate
Timepoint
End of menstrual cycle
Method of measurement
Sonography
3
Description
Ovarian hyperstimulation syndrome
Timepoint
End of menstrual cycle
Method of measurement
Clinical and ultrasound
4
Description
Side effects such as headaches, dizziness, blurred vision, nausea and vomiting
Timepoint
During the treatment cycle
Method of measurement
Ask the patient
Intervention groups
1
Description
Prescription of 2tablet ( 40mg) tamoxifenfir 5 days from day 3-7 of menstrual cycle, serial sonography in day 12-16 was done for evaluation of endometrial thickness and pattern and number of mature follicles. And after reaching at least are follicle to ≥18mm, injection of 5000Iu HCG was done and ultimately control the incidence of pregnancy in women
Category
Treatment - Drugs
2
Description
Prescription of 150mg clomiphen citrate for 5 days from day 3-7 of menstrual cycle, serial sonography in day 12-16 was done for evaluation endometrial thickness and pattern and number of mature follicles, and after reaching at least one follicle to ≥18mm,5000Iu HCG was injected and ultimately control the incidence of pregnancy in women
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility clinic, Alzahra hospital
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research-Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Vice Chancellor for research-Guilan University of Medical Sciences l, Namjoo street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research-Guilan 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
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 Guilan university of Medical Science
Other areas of specialty/work
Street address
Rasht.Namjo street.Alzahra hospital.Reproductive Health Research Center
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
drzibazahiri@gums.ac.ir drzibazahiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
B.S.midwife
Other areas of specialty/work
Street address
Rasht.Namjo street.Alzahra hospital.Reproductive Health Research Center
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
h_fertility@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)