This is a clinical trial study. The subjects in this trial are infertile women with poly cystic ovary syndrome who were referred to a gynecology clinic. Patients were selected after 12 months of intercourse without contraception is not pregnant and have normal prolactin and thyroid function test and Uterine. Tubal infertility problems caused infertility role out with hysterosalpangiography. Honeycomb view ovaries on ultrasound, amenorrhea and oligo menorrhea, too endometrial thickness are inclusion criteria of the patients in this study. Other causes of infertility in women such as endometriosis or other diseases, such as internal and surgical patients or have ovarian hyper stimulation syndrome in initial ultrasound are excluded. Patients were randomly divided into two groups. The first group, receive tamoxifen + letrozole, common poly cystic ovary syndrome treatment regimen and second group receive Nigella + black pepper with fixed doses. Tamoxifen (10 mg 2 tab QD), letrozole (2/5 mg 2 tab QD) from third to eight day of menstrual cycle. Herbal regimen of nigella (5 cap) +black pepper (5 cap) Q8h from third to eight day of menstrual cycle each cap dose is 550 mg. On the eighth day of the menstrual cycle vaginal ultrasound is performed. Based on the size and number of follicles medication dosage adjusted. If the size of the follicles is less than 18 mm longer continue treatment for up to five days and re-ultrasound done twelfth day cycle. If the size of follicles between 25-18 mm, and the number is less than 14, HCG injections are injected from 500 to 10,000 units. The effects of drugs and variables such as the size of the follicles and endometrial thickness and incidence of adverse events such as OHSS are examined with trans vaginal ultrasound. Pregnancy diagnosis of patients based on the results of ultrasound tests are headline ß- HCG. The main objective of this study was to compare the effect of letrozole+ tamoxifen with nigella + black pepper in the treatment of infertility in women with poly cystic ovarian syndrome. It is hoped we can chose a vegetarian diet or medication that is more effective and cost less.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062121653N6
Registration date:2017-03-18, 1395/12/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-18, 1395/12/28
Registrant information
Name
Athar Rasekh Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5432 6602
Email address
a.rasekh@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahrom University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of nigella sativa +pepper nigrum (nigrum Piper )with letrozole + tamoxifen in infertile woman with polycystic ovary syndrom
Public title
The effect of nigella sativa+pepper nigrum on infertility in women with PCOS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: infertile women with poly cystic ovary syndrome who are not pregnant after 12 months of unprotected intercourse.
Exclusion criteria: women with other causes of infertility such as endometriosis or other surgical or internal problems who have not PCOS criteria. also,women who have evidence of ohss in primary sonography.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences, Motahari St.
City
Jahrom
Postal code
Approval date
2016-04-05, 1395/01/17
Ethics committee reference number
IR.JUMS.REC.1394.206
Health conditions studied
1
Description of health condition studied
Infertile women with polycystic ovarian syndrom
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Follicle size
Timepoint
Eighth and twelfth day of menstural cycle
Method of measurement
Sonography
2
Description
number of follicles
Timepoint
eighth and twelfth day of menstural cycle
Method of measurement
sonography
3
Description
endometrial thickness
Timepoint
eighth and twelfth day of menstural cycle
Method of measurement
sonography
Secondary outcomes
1
Description
ovarian hyper stimulation syndrom
Timepoint
In the entire course of treatment
Method of measurement
Sonography
Intervention groups
1
Description
Intervention1:
Tab tamoxifen 10mg (two tablet per day) +Tab letrozole 2/5mg (two tablet per day) from third to eighth day of menstrual cycle
Category
Treatment - Drugs
2
Description
Intervention 2:
cap powder of nigella 550 mg+cap powder of pepper 550 mg(po Q8h) from third to eighth day of menstrual cycle for three month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Rasekh Infertility Clinic
Full name of responsible person
Dr Rasekh
Street address
Dr Rasekh Infertility Clinic, 22 Bahman St.
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr kavus solhjo
Street address
Jahrom University of Medical Sciences, Motahari St.
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Rasekh Jahromi Athar
Position
Genicologist
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences, Motahari St.
City
Jahrom
Postal code
Phone
+98 71 5422 1040
Fax
Email
Drrasekh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Rasekh Athar
Position
Genicologist
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences, Motahari St.
City
Jahrom
Postal code
Phone
+98 71 5422 1040
Fax
Email
drrasekh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
jahrom university of medical siences
Full name of responsible person
Farzaneh Najafian
Position
student
Other areas of specialty/work
Street address
jahrom,jahrom university of medical siences,Iran
City
jahrom
Postal code
-
Phone
+98 71 5437 4122
Fax
Email
najafian_f343@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)