Comparison of the effect of Palm pollen regimen with Letrozole and Tamoxifen in treatment of infertile women in Jahrom City
Design
Randomized clinical trial with parallel groups
Settings and conduct
In this study, patients with infertility who referred to Jahrom clinic during three months were randomly divided into two groups: control and Intervention.
In Intervention group take herbal diet Palm pollen 120mg/kg as 500 mg capsules.The control group will receive regular treatment of infertility including letrozole and tamoxifen(Tamoxifen tab 10mg Bid and Letrozol 2.5 mg Bid). Finally, on the eighth day of the menstrual cycle, vaginal sonography will be performed to evaluate the effects of drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertile women who had no pregnancy history after 12 months of unprotected intercourse
Exit criteria: Women with endometriosis
Intervention groups
Intervention group: herbal diet Palm pollen 120mg/kg as 500 mg capsules.
control group:Tamoxifen tab 10mg Bid and Letrozol 2.5 mg Bid from 3th days of menstruation
Main outcome variables
The frequency of pregnancy after each treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150407021653N16
Registration date:2019-01-18, 1397/10/28
Registration timing:registered_while_recruiting
Last update:2019-01-18, 1397/10/28
Update count:0
Registration date
2019-01-18, 1397/10/28
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
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2019-05-22, 1398/03/01
Trial completion date
empty
Scientific title
Comparison of the effect of Palm pollen regimen with Letrozole and Tamoxifen in treatment of infertile women in Jahrom City
Public title
Comparison of the effect of Palm pollen regimen with Letrozole and Tamoxifen in treatment of infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women who had no pregnancy history after 12 months of unprotected intercourse
Exclusion criteria:
Women with endometriosis
Age
From 18 years old to 40 years old
Gender
Female
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
128
Actual sample size reached:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers table
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
Jahrom University of Medical Sciences
Street address
Jahrom, Motahari Blvd. Pardis building
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2018-08-05, 1397/05/14
Ethics committee reference number
IR.JUMS.REC.1397.03514
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Determine the frequency of pregnancy after each treatment
Timepoint
2 years
Method of measurement
Based on the ß-HCG test
Secondary outcomes
1
Description
The average thickness of the endometrium before and after treatment
Timepoint
On the eighth day of the menstrual cycle
Method of measurement
Vaginal Sonogarphy
2
Description
Frequency of ovarian follicles count before and after treatment
Timepoint
On the eighth day of the menstrual cycle
Method of measurement
Vaginal Sonogarphy
Intervention groups
1
Description
Intervention group: herbal diet Palm pollen 120mg/kg as 500 mg capsules with citresin anti-allergic acid tablets of 10 mg every 8 hours to prevent the onset of allergy from the first day of menstruation.
Category
Treatment - Drugs
2
Description
control group:Tamoxifen tab 10mg Bid and Letrozol 2.5 mg Bid from 3th days of menstruation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Rasekh Infertility Clinic
Full name of responsible person
Athar Rasekh Jahromi
Street address
Jahrom Avenue 22 Bahman Dr. Rasekh Infertility Clinic
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5422 7658
Email
a.rasekh@jums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Athar Rasekh Jahromi
Street address
Jahrom، street 22 Bahman،opposite the governorate
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5422 7658
Email
drrasekh@yahoo.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Athar Rasekh Jahromi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pardis building,Motahari Blvd.,Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5422 1040
Email
Drrasek@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Athar Rasekh Jahromi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pardis building, Motahari Blvd, Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5422 1040
Email
Drrasekh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Pardis Abtahian
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Pardis building, Motahari Blvd, Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5422 1040
Email
pardis.abtahian1372@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available