Comparison of live births rate in frozen embryo transfer cycles with and without intramuscular injection of human chorionic gonadotropin.
Design
A randomized clinical trial with control group, open label, two arm parallel group design of 100 patients. Randomization is performed using a computer-generated random assignment schedule for each patient. Sealed and numbered envelopes are used to conceal the treatment allocation until randomization.
Settings and conduct
Female infertility Clinic of ROYAN institute.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Infertile women candidates for frozen embryo transfer; Age 20-40 years; Body Mass Index under than 30 Kg/m2; Having at least three good quality embryos. Conditions for not entering the study: Women with hematologic and autoimmune disorders; Couples with chromosomal and genetic abnormalities; Women with uterine anomalies; Women with uterine and ovaries surgical history; Women with endometriosis and adenomyosis; Women with hydrosalpinx; Women with uterine fibroids; Women with history of recurrent abortion or recurrent implantation failure; Severe male factor infertility (azoospermia); Embryo donation cycle; Endometrial thickness less than 8 millimeter on the day of embryo transfer.
Intervention groups
Intervention group: The group of frozen embryo transfer with intramuscular injection of human chorionic gonadotropin.
Control group: The group of frozen embryo transfer without intramuscular injection of human chorionic gonadotropin.
Main outcome variables
Live births rate
General information
Reason for update
Acronym
FET-HCG
IRCT registration information
IRCT registration number:IRCT20080831001141N32
Registration date:2020-12-28, 1399/10/08
Registration timing:registered_while_recruiting
Last update:2020-12-28, 1399/10/08
Update count:0
Registration date
2020-12-28, 1399/10/08
Registrant information
Name
Kiandokht Kiani
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 7960
Email address
kiandokht.kiani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-01, 1399/04/11
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Intramuscular Injection of Triple Doses of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles
Public title
Intramuscular Injection of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women candidates for frozen embryo transfer
Age 20-40 years
Body Mass Index under than 30 Kg/m2
Having at least three good quality embryos
Exclusion criteria:
Women with hematologic and autoimmune disorders
Couples with chromosomal and genetic abnormalities
Women with uterine anomalies
Women with uterine and ovaries surgical history
Women with endometriosis and adenomyosis
Women with hydrosalpinx
Women with uterine fibroids
Women with history of recurrent abortion or recurrent implantation failure
Severe male factor infertility (azoospermia)
Embryo donation cycle
Endometrial thickness less than 8 millimeter on the day of embryo transfer
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 6. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 200 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope.
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 Royan Institute
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Approval date
2020-06-30, 1399/04/10
Ethics committee reference number
IR.ACECR.ROYAN.REC.1399.015
Health conditions studied
1
Description of health condition studied
Implantation of embryo
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Live birth rate; live birth is defined in which a live fetus is delivered beyond 20 completed weeks of gestational.
Timepoint
Only once; at least 20 weeks after embryo transfer.
Method of measurement
Clinical information.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group of frozen embryo transfer with intramuscular injection of human chorionic gonadotropin. In this group, endometrial preparation for embryo transfer will be through the standard protocol using a gonadotropin-releasing hormone agonist. Patients receive 5,000 IU of human chorionic gonadotropin by intramuscular injection, 72 hours before embryo transfer, on the day of embryo transfer, and 72 hours after embryo transfer.
Category
Treatment - Other
2
Description
Control group: The group of frozen embryo transfer without intramuscular injection of human chorionic gonadotropin. In this group, endometrial preparation for embryo transfer will be through the standard protocol using a gonadotropin-releasing hormone agonist. Embryo transfer will be done without human chorionic gonadotropin intramuscular injection.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of ROYAN
Full name of responsible person
Mehri Mashayekhy
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ROYAN Institute
Full name of responsible person
Parvaneh Afsharian
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2674
Fax
+98 21 2230 6481
Email
pafshar@royaninstitute.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ROYAN Institute
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Mehri Mashayekhy
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Mehri Mashayekhy
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Mehri Mashayekhy
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical study report (published article)
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Available to the public.
Under which criteria data/document could be used
Scientific use by citing the source.
From where data/document is obtainable
Dr. Mehri Mashayekhy
Email: dr.mashayekhy@yahoo.com
What processes are involved for a request to access data/document