Effect of adding letrozole to gonadotropin on pregnancy outcomes
Design
Clinical trials, sample size 100 patients, phase 3 of the clinical trial, with the control group, with parallel groups, without blindness, randomized with an enveloped packet.
Settings and conduct
This Randomized clinical trial without blindness is conducted for evaluating the effect of intrauterine injection of PRP in Asherman patients referred to Shahid Sadoughi Hospital or Research and Clinical Center for Infertility, Yazd, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertile patients which are the candidate for ART.
Exclusion criteria: History of endocrine disorders, Intrauterine abnormality (uterine polyp & submucosal fibroma & intrauterine adhesions), Azoospermia of partner Severe endometriosis
Intervention groups
Intervention group: since the second day of the cycle all patients Will receive 150 unit gonadotropin, all patients in this group will receive 5 mg letrozole orally science the second day of the cycle When dominant follicle reached to 12-13 mm, antagonist.25 mg will be injected daily subcutaneously. when dominant follicle reaches 17 mm, final triggering will be done.
Control group: since the second day of the cycle all patients Will receive 150 unit gonadotropin, When the dominant follicle reached 12-13 mm, antagonist.25 mg will be injected daily subcutaneously. when dominant follicle reaches 17 mm, final triggering will be done.
Main outcome variables
Chemical pregnancy rate, clinical pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110509006420N19
Registration date:2018-09-18, 1397/06/27
Registration timing:registered_while_recruiting
Last update:2018-09-18, 1397/06/27
Update count:2
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding letrozole to gonadotropin on pregnancy outcomes in patients who are the candidate for assisted reproductive techniques
Public title
Letrozole in assisted reproductive techniques protocol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to the Infertility Center, which is undergoing ovulation induction for assisted reproductive techniques.
Exclusion criteria:
History of endocrine disorders
Intrauterine abnormality (uterine polyp & sub mucosal fibroma & intrauterine adhesions)
Azoospermia of partner
Severe endometriosis
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Using computer-generated random numbers in wrapped,
unlabeled envelope each holding a unique number.
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
Yazd research center for infertility-Shahid Sadoughi University of Medical Science
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
Ir.SSU.RSI.REC.1397.009
Health conditions studied
1
Description of health condition studied
female Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
15 days after embryo transfer
Method of measurement
Blood laboratory kit
2
Description
Clinical pregnancy
Timepoint
3 weeks after positive beta-h Cg
Method of measurement
Observation of fetal heart activity by transvaginal ultrasonography
Secondary outcomes
1
Description
Miscarriage rate
Timepoint
20 weeks after intervention
Method of measurement
Absence of fetal heart activity in ultra sound sonography
Intervention groups
1
Description
Control group: Antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.
Category
Treatment - Drugs
2
Description
Intervention group: antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously, all patients in this group will receive 5 mg letrozole (Iran hormone-Iran)) orally science send day of cycle, When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reaserch and clinical for infertility
Full name of responsible person
Abbas aflatoonian
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas/aflatoonian@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Abbas aflatoonian
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas/aflatoonian@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the privacy of patients
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The study protocol, the statistical analysis map, the clinical study report will be available after the publishing of the article.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
use in the retrospective study
From where data/document is obtainable
use in the retrospective study
What processes are involved for a request to access data/document
Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.