A clinical trial to compare the frozen embryo transfer (FET) via letrozole and recombinant human FSH (rhFSH) induction with GnRH agonist and estradiol valerate in infertile women with unsuccessful embryo transfer history
To compare the frozen embryo transfer (FET) via letrozole and recombinant human FSH (rhFSH) induction with GnRH agonist and estradiol valerate in infertile women with unsuccessful embryo transfer history.
Design
In this pragmatic single-blind, controlled clinical trial, 142 women with unsuccessful embryo transfer history were assigned into parallel groups using the table of random numbers in a community-based setting.
Settings and conduct
Women with unsuccessful embryo transfer history at the Milad Fertility Clinic, Mashhad, were chosen. In this single-blind study, the data collector was blind to group assignment and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range of 22-40 years; history of more than twice unsuccessful embryo transfer; the male does not have severe infertility.
Exclusion criteria: Severe endometriosis stage 3 and 4; fibroma >4 cm; non-frozen-thawed embryo transfer; necrotic embryonic.
Intervention groups
The intervention group will receive 2.5 mg of letrozole in cycle day 3 for 5 days and 75 ml of IU rhFSH in cycle day 9. The control group will receive 500 μg of GnRH agonist in cycle day 21 and 4 mg of estradiol valerate in next cycle day 3.
Main outcome variables
Evaluation and comparison of clinical pregnancy two and six weeks after embryo transfer in the intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181109041597N1
Registration date:2019-01-07, 1397/10/17
Registration timing:registered_while_recruiting
Last update:2019-01-07, 1397/10/17
Update count:0
Registration date
2019-01-07, 1397/10/17
Registrant information
Name
Elnaz Zohdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3853 4021
Email address
zohdie961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the frozen embryo transfer (FET) via letrozole and recombinant human FSH (rhFSH) induction with GnRH agonist and estradiol valerate in infertile women with unsuccessful embryo transfer history
Public title
The frozen embryo transfer in infertile women with unsuccessful embryo transfer history.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 22-40 years
History of more than twice unsuccessful embryo transfer
The male does not have severe infertility
Exclusion criteria:
Severe endometriosis stage 3 and 4
Fibroma >4 cm
Non-frozen-thawed embryo transfer
Necrotic embryonic
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
142
Randomization (investigator's opinion)
Randomized
Randomization description
Totally 142 women with unsuccessful embryo transfer history at the Milad Fertility Clinic, Mashhad, were chosen. The participants were allocated into two groups of intervention and control using the table of random numbers based on computer programs
Blinding (investigator's opinion)
Single blinded
Blinding description
Women with unsuccessful embryo transfer history at the Milad Fertility Clinic, Mashhad, were chosen. In this single-blind study, the data collector was blind to group assignment and the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2018-11-01, 1397/08/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.412
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
Two and six weeks after embryo transfer
Method of measurement
Human chorionic gonadotropin (hCG) test and transvaginal sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive 2.5 mg of letrozole in cycle day 3 for 5 days and 75 ml of IU rhFSH in cycle day 9.
Category
Treatment - Other
2
Description
Control group: The control group will receive 500 μg of GnRH agonist in cycle day 21 and 4 mg of estradiol valerate in next cycle day 3.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Fertility Clinic
Full name of responsible person
Elnaz Zohdi
Street address
Milad Fertility Clinic, East Razi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
zohdie961@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Elnaz Zohdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Milad Fertility Clinic, East Razi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
zohdie961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elnaz Zohdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Milad Fertility Clinic, East Razi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
zohdie961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elnaz Zohdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Milad Fertility Clinic, East Razi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
zohdie961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
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
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Elnaz Zohdi provides the analysis code to the applicants via email: zohdie961@mums.ac.ir
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.