Comparing clinical outcome of letrozole versus hormone replacement for endometrial preparation in women with normal menstrual cycles for transferring frozen embryo .
Design
Randomized controlled trial
Settings and conduct
Patients in the infertility center of hazrat Zeynab Hospital will be undergo of:Intervention group: Administration of letrozole tab 5 mg from 3th day of menstrual cycle until the 7th day in the intervention group .
Control group: administration of esteradiol from the 2th or 3th day of menstruation until the day 10th.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18-42 years old women, having freeze embryos,
normal uterine cavity, BMI <35 kg/m2.
Exclusion criteria:maternal underlying disease, hydrosalpinx,
Intervention groups
Intervention group: Administration of letrozole tab 5 mg from 3th day of menstrual cycle until the 7th day in the intervention group .
Control group: administration of esteradiol from the 2th or 3th day of menstruation until the day 10th.
Main outcome variables
Clinical pregnancy rate, Chemical pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190327043121N1
Registration date:2019-05-26, 1398/03/05
Registration timing:registered_while_recruiting
Last update:2019-05-26, 1398/03/05
Update count:0
Registration date
2019-05-26, 1398/03/05
Registrant information
Name
leila ghasempour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2365
Email address
leilaghasempour97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-26, 1398/03/05
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Frozen embryo transfer: Randomized clinical trial on endometrial preparing by letrozole versus hormone replacement cycle
Public title
letrozole versus hormone replacement cycle in endometrial preparing in embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-42 years old
Freeze embryos
Normal uterine cavity, without any endometrial polyp or lesion.
BMI <35 kg/m2
Exclusion criteria:
Maternal underlying disease,
Hydrosalpinx
Age
From 18 years old to 42 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
167
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization:patients who has frozen embryo will be randomized based on the randomization table, after which is derived from www.randomization.org.
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
Ethics committee of Shiraz University of Medical Science
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
IR.SUMS.REC.1397.406
Health conditions studied
1
Description of health condition studied
infertility patients going ivf cycle with frozen embryo
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
2 months after embryo transfer
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Chemical pregnancy rate
Timepoint
14 days after transferring the embryo
Method of measurement
Pregnancy Test
Intervention groups
1
Description
Intervention group: Administration of letrozole tab 5 mg from 3th day of menstrual cycle until the 7th day.
Category
Treatment - Drugs
2
Description
Control group: administration of esteradiol from the 2th or 3th day of menstruation until the day 10th.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Zeinab Hospital
Full name of responsible person
Leila Ghasempour Shirazi
Street address
Hazrate Zeinab Hospital, Defae moghadas square
City
Shiraz
Province
Fars
Postal code
7134544119
Phone
+98 71 3233 2365
Fax
+98 71 3233 2365
Email
leilaghasempour97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
71348 -44119
Phone
+98 71 3235 2365
Fax
+98 71 3235 2365
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Leila Ghasempour Shirazi
Position
Infertility fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetrics department , Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3233 2365
Email
leilaghasempour97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Alamtaj Samsami Dehaghani
Position
Infertility fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetrics department , Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3233 2365
Email
leilaghasempour97@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Ghasempour Shirazi
Position
Infertility fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetrics department , Faghihi Hospital, Zand Street
City
shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3233 2365
Email
leilaghasempour97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
hormonal data, ovarian stimulation data, embryo transfer data, pregnancy outcome
When the data will become available and for how long
6 month after acceptance of paper
To whom data/document is available
People who want to do work in this area and have scientific documentation can
Under which criteria data/document could be used
Valid Scientific Persons By Presenting Relevant Documents
From where data/document is obtainable
an email to corresponding author
What processes are involved for a request to access data/document
Accepting permission from the Shiraz University of Medical Sciences's security and confirming the receipt of the file