Comparison of therapeutic results of letrozole, tamoxifen, estradiol and vitamin E regimen with letrozole, tamoxifen and estradiol regimen in stimulating ovulation in infertile women with polycystic ovary syndrome: a double-blind randomized clinical trial study
Comparison of therapeutic results of letrozole, tamoxifen, estradiol and vitamin E diet with letrozole, tamoxifen and estradiol diet in stimulation of ovulation in infertile women with polycystic ovary syndrome
Design
In this study, computerized block randomization (12 blocks) will be done.
An independent epidemiologist who is not involved in conducting the study will use a randomized block computer program (stata software) to generate allocation codes.Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 90 patients.
Settings and conduct
This study will be conducted as a prospective clinical trial on infertile women with PCOS who referred to Jahrom women's clinic during 1401-1402.
Participants/Inclusion and exclusion criteria
Entry criteria:
Infertile women with polycystic ovary syndrome who have not had a history of pregnancy after 12 months of unprotected intercourse / at least 40 years old
Exit criteria:
Non-consent to participate in the study/drug sensitivity to letrozole or tamoxifen or estradiol or vitamin E/the existence of any other pathology that has led to infertility in the patient or his wife/liver or kidney dysfunction/diabetes mellitus type one or two/disorders Thyroid/congenital adrenal hyperplasia/abnormal hysterosalpingography
Intervention groups
Infertile women with polycystic ovary syndrome who have not had a history of pregnancy after 12 months of unprotected intercourse / at least 40 years old
Main outcome variables
Pregnancy, follicle size, follicle number, follicle thickness, multiple births, drug side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150407021653N20
Registration date:2023-12-14, 1402/09/23
Registration timing:prospective
Last update:2023-12-14, 1402/09/23
Update count:0
Registration date
2023-12-14, 1402/09/23
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
2024-01-30, 1402/11/10
Expected recruitment end date
2024-04-29, 1403/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic results of letrozole, tamoxifen, estradiol and vitamin E regimen with letrozole, tamoxifen and estradiol regimen in stimulating ovulation in infertile women with polycystic ovary syndrome: a double-blind randomized clinical trial study
Public title
Comparison of therapeutic results of letrozole, tamoxifen, estradiol and vitamin E regimen with letrozole, tamoxifen and estradiol regimen in stimulating ovulation in infertile women with polycystic ovary syndrome: a double-blind randomized clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender
Infertile who have not had a history of pregnancy after 12 months of unprotected intercourse
Suffering from polycystic ovary syndrome
At least 40 years old
Exclusion criteria:
Non-consent to participate in the study
drug sensitivity to letrozole or tamoxifen or estradiol or vitamin E
the existence of any other pathology that has led to infertility in the patient or his wife
liver or kidney dysfunction
diabetes mellitus type one or two
Thyroid disordes
congenital adrenal hyperplasia
abnormal hysterosalpingography
Age
From 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, computer block randomization (block size of 12) will be performed
An independent epidemiologist not involved in the study will use a computerized block randomization program to generate allocation codes. The randomization sequences will be placed in sealed, light-resistant envelopes.The research assistant will open the sealed, numbered and opaque envelopes containing the allocation codes. After signing the informed consent form, the eligible participants will be divided into two equal groups of Letrozole, Tamoxifen, Estradiol, Vitamin E and Letrozole, Tamoxifen. , estradiol
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding is done bilaterally. None of the participants and outcome assessors know which study group someone is in. It should be mentioned that at the beginning of the study, the general introduction of the study groups will be done for the participants and after getting their consent, random allocation will be done and the participants will be randomly assigned to two treatment groups A and B. Also, the controller, who examines the patients from the beginning to the end of the study in the obstetrics and gynecology clinic, is not aware of which group the patient is in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethic committee of Jahrom university of medical science
Street address
Motahari Boulevard, Shahidan Firouzi Street, Jahrom University of Medical Sciences
City
jahrom
Province
Fars
Postal code
7414846199
Approval date
2023-02-19, 1401/11/30
Ethics committee reference number
IR.JUMS.REC.1401.135
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pregnancy
Timepoint
One day after the fall in menstruation.
Method of measurement
ß-HCG titer test
Secondary outcomes
1
Description
Follicle size, follicle number and follicle thickness
Timepoint
Days 3, 7 and 12 of the cycle
Method of measurement
sonography
2
Description
multiple births
Timepoint
Week 6 of pregnancy
Method of measurement
sonography
3
Description
Drug side effects
Timepoint
The total time of the intervention
Method of measurement
Examination by the doctor and self-reported by the patient based on previous training
Intervention groups
1
Description
Intervention group: People participating in the study are randomly divided into two groups A and B with equal sample size.For group A, from the third to the seventh day of the menstrual cycle, daily letrozole at a dose of 5 mg (two tablets of letrozole 2.5 mg), tamoxifen at a dose of 20 mg (10 mg twice a day), estradiol and vitamin E at a dose of 100 mg is prescribed daily for 25 days
Category
Treatment - Drugs
2
Description
Control group: People participating in the study are randomly divided into two groups A and B with equal sample size.For group B (control), from the third to the seventh day of the menstrual cycle, daily letrozole at a dose of 5 mg (two tablets of letrozole 2.5 mg), tamoxifen at a dose of 20 mg (10 mg twice a day), estradiol for 25 The day is prescribed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Obstetrics and Gynecology Clinic of Jahrom
Full name of responsible person
Athar Rasekh
Street address
Honari clinic-Alley 25-Motahari Blvd- Jahrom City
City
Jahrom
Province
Fars
Postal code
7415713945
Phone
+98 71 5434 2006
Email
Drrasekh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavoos solhjoo
Street address
Motahari Boulevard, Shahidan Firouzi Street, Jahrom University of Medical Sciences
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0409
Email
pazhuheshi@jums.ac.ir
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 raskh
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 25 Ave,Mothari Blvd,Jahrom City
City
Jahrom
Province
Fars
Postal code
7415713945
Phone
+98 71 5434 2006
Email
a.rasekh@jums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
athar raskh
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 25 Ave,Mothari Blvd,Jahrom City
City
Jahrom
Province
Fars
Postal code
7415713945
Phone
+98 71 5434 2006
Email
a.rasekh@jums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
mohamad javad karimi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Jahrom Motahari Blvd. Shahidan Firouzi St. Shahid Daneshpur Blvd
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 3786 7364
Email
mjkarimi7413@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