Assessing the effect of intrauterine injection of human gonadotropin on the outcome of embryo transfer cycles
Design
Randomized clinical trial with control group with parallel groups design of 150 patients in each group
Settings and conduct
The present study is a randomized clinical trial designed on 300 women referred to Yas Infertility Center in 1398. The available sampling method will be used to select the samples. The study sample will be assigned to one of two groups using random allocation by block randomization at a ratio of 1: 1: Intervention group will receive 500 units of HCG prior to embryo transfer by intrauterine injection and The control group will not receive any intervention before embryo transfer. Embryo transfer will be performed on day 2 or 3 after oocyte harvest. In control group, embryo transfer will be performed without intrauterine injection of HCG. A pregnancy test will be performed 2 weeks after the embryo transfer and 3 weeks after a positive pregnancy test. An ultrasound examination will be performed to see the number and location of the pregnancy sac and confirm the fetal heart rate.
Participants/Inclusion and exclusion criteria
Women with primary infertility who have had at least one fetal transfer and have at least one Grade A or B frozen fetus and are younger than 40 years.
Intervention groups
The intervention group will receive 500 units of HCG prior to embryo transfer via intrauterine injection and the control group will receive no intervention before embryo transfer.
The effect of intrauterine injection of human gonadotropin (HCG) on the outcome of embryo transfer cycles in women
Public title
Effect of intrauterine injection of human gonadotropin (HCG) on the outcome of embryo transfer cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with primary infertility who have had at least one fetal transfer
At least have one Grade A or B frozen embryo
Exclusion criteria:
Age over 40 years
BMI over 30 kg/m2
Infertility with severe male cause such as azoospermia
Uterine myoma or history of myomectomy
Endometriosis Grade 3 and 4
Hydrosalpingitis
The duration of freezing of the fetus more than 2 years
Age
To 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation by balanced blocked randomization with the 1:1 proportion of intervention group to control group
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 Tehran University of Medical Sciences
Street address
Poorsina street
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.872
Health conditions studied
1
Description of health condition studied
Primary infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Pregnancy rate
Timepoint
2 weeks after embryo transfer
Method of measurement
Sonography
Secondary outcomes
1
Description
Abortion rate
Timepoint
Before the 20th week of pregnancy
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: 40 µl of tissue culture medium containing 500 units of HCG by intrauterine injection
Category
Treatment - Drugs
2
Description
Control group: Embryo transfer without intrauterine injection of HCG
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas infertility center
Full name of responsible person
Mahshid Karimi
Street address
Poursina
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8890 4172
Email
mkarimi6471@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Poorsina
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahshid Karimi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karim Khan Zand Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Fax
Email
s_khazaeii@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahshid Karimi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karim Khan Zand Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Fax
Email
s_khazaeii@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahshid Karimi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karim Khan Zand Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Fax
Email
s_khazaeii@yahoo.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
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