Determining the effect of intrauterine hCG injection before embryo transfer on pregnancy rate in frozen embryo transfer cycles
Design
Clinical trial with parallel control group, randomized, phase 3 on 300 patients. Block randomization method will be used for randomization
Settings and conduct
Patients are studied in two groups at Shariati hospital in Tehran: After preliminary preparation of patients, the target group will be injected with 500 hCG units in the uterine cavity 4 minutes before embryo transfer, and the control group will be injected with 0.1 cc of media solution in the same way. In both groups, treatment with estradiol and progesterone will continue, and 2 weeks later a pregnancy test (hCG test) will be performed on the patients.
Participants/Inclusion and exclusion criteria
In this clinical trial , among women with infertility problems referred to Dr. Shariati Hospital in Tehran, women with frozen fetuses are included in the study.
Inclusion criteria are:
age 20 to 39 years; Good quality embryos A and B and the first frozen embryo transfer.
exclusion criteria:
More than 40 years old;Male infertility TESE (percutaneous aspiration of sperm from the epididymis) and PESA (extraction of sperm from the testis) and azoospermia; History of myomectomy; Existence of hydrosalpinx; Existence of fibroids with compressive effect on endometrium; Endometriosis
Intervention groups
The intervention group will inject 500 hCG units (volume 0.1 cc) into the uterine cavity on day 2-3 of menstruation, 4 minutes before embryo transfer, then the embryo will be transferred with grade A-B cleavage stage.
The control group will receive 0.1 cc media solution instead hCG.
Main outcome variables
Presence of a pregnancy sac and the presence of a fetal heart in followed up ultrasound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110602006689N4
Registration date:2021-09-08, 1400/06/17
Registration timing:prospective
Last update:2021-09-08, 1400/06/17
Update count:0
Registration date
2021-09-08, 1400/06/17
Registrant information
Name
Sedigheh Hosseinimousa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 8810
Email address
hoseinimosa@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-22, 1400/06/31
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intrauterine hCG injection before embryo transfer on pregnancy rate in frozen embryo transfer cycles
Public title
The effect of intrauterine hCG injection before embryo transfer on pregnancy rate in frozen embryo transfer cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-39
Embryo with grade A and B
First transfer
Exclusion criteria:
Age 40 or above 40
Male infertility TESE or PESA and azospermia
History of myomectomy
Hydrosalphinx
Myoma with compressive effect
Endometriosis
Age
From 20 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method:
We use the block randomization method to randomize subjects into groups that result in equal sample sizes.
We use the block size 4. From the following blocks, first select 1 by accident and divide the samples into two groups according to the order and fill the blocks
A for intervention and B for placebo
B A B A 2) B B A A 1)
B A A B 4) A B B A 3)
A A B B 6) A B A B 5)
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single-blind and the participants would not know about the type of treatment.
Placebo
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
Ethics Committee, Tehran University of Medical Sciences, Poorsina Street, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-03-13, 1399/12/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1258
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Pregnancy
Timepoint
2 weeks after embryos transfer
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Clinical pregnancy rate
Timepoint
From 12 weeks
Method of measurement
Heart rate presence on ultrasound
Intervention groups
1
Description
Intervention group: in 2-3rd day of mensuration period, after baseline ultrasound, ensuring uterine and ovarian suppression and ovarian pathologies role out, 2 mg estradiol will be started every 12 hours and will be adjusted based on endometrial response. After preparing the endometrium, the thickness of the endometrium reaches the appropriate level by performing serial ultrasound, the participants receives progesterone suppositories for 4 days and 4 minutes before embryo transfer, 500 units of hCG (volume 0.1 cc) will be injected into the uterine cavity with Cook transfer catheter, then the embryo will be transferred with grade A-B cleavage stage.
Category
Treatment - Drugs
2
Description
Control group: in 2-3rd day of mensuration period, after baseline ultrasound, ensuring uterine and ovarian suppression and ovarian pathologies role out, 2 mg estradiol will be started every 12 hours and will be adjusted based on endometrial response. After preparing the endometrium, the thickness of the endometrium reaches the appropriate level by performing serial ultrasound, the participants receives progesterone suppositories for 4 days and 4 minutes before embryo transfer, 0.1 cc of media solution will be injected into the uterine cavity with a Cook transfer catheter and then the embryo will be transferred with grade A-B cleavage step.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Unit, Shariati Hospital
Full name of responsible person
Dr. Sedighe Hosseinimousa
Street address
Department of Infertility, Shariati Hospital, Tehran University of Medical Sciences, North Karegar Street
City
Tehran
Province
Tehran
Postal code
1466938664
Phone
+98 21 8822 0050
Email
hoseinimosa@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhoondzadeh
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8822 0050
Fax
+98 21 8822 0050
Email
ivfshariati69@gmail.com
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
Dr Sedighe Hoseinimosa
Position
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
hoseinimosa@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sedighe Hoseinimosa
Position
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
hoseinimosa@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sedighe Hoseinimosa
Position
Infertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 8810
Fax
+98 21 8822 0050
Email
hoseinimosa@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Starting 9 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
No other condition is considered
From where data/document is obtainable
hoseinimosa@sina.tums.ac.ir
What processes are involved for a request to access data/document