Evaluation of the effect of intrauterine injection of human chorionic gonadotropin (HCG) before embryo transfer (ET) on pregnancy outcomes in assisted reproductive cycles (IVF / ICSI)
Determining the effect of intrauterine injection of human chorionic gonadotropin (HCG) on pregnancy outcomes in IVF / ICSI cycles
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 per 100 patients. With randomize all location software, individuals are assigned to two intervention and control groups, and matching both groups will be done based on age / body mass index and antimullerian hormone level.
Settings and conduct
Patients are randomly assigned to the intervention and control groups. Both groups are assimilated in terms of "BMI" AMH. It is injected 15 minutes before transfer to the lithotomy position and after the speculum is placed, and it is not injected in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hip women under 40 years of age who undergo the necessary treatment protocols for IVF / ICSI are endocrine candidates for grade A or B embryos.
Exclusion criteria: Azoospermia through sperm test / History of uterine surgery through history / Severe endometriosis through history Ultrasound findings / Hydrosalpinx through ultrasound / Hysterosalpingography / Sub endocrine disorders such as diabetes mellitus / More repeated failures equal to 3 times the history
Intervention groups
In the intervention group, a 5000-unit HCG vial with Karma brand is mixed with 0.4 ml of embryo glue and 40 μl of which is equivalent to 500 units of HCG.
Main outcome variables
AMH; Chemical pregnancy; Implantation; Cilinical pregnancy; Ongoing pregnancy; Number of embryos transferred per cycle; Type of embryo transferred; Follicle size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160703028756N7
Registration date:2021-10-16, 1400/07/24
Registration timing:registered_while_recruiting
Last update:2021-10-16, 1400/07/24
Update count:0
Registration date
2021-10-16, 1400/07/24
Registrant information
Name
Elham Naghshineh
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
naghshineh@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-29, 1400/06/07
Expected recruitment end date
2021-11-28, 1400/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intrauterine injection of human chorionic gonadotropin (HCG) before embryo transfer (ET) on pregnancy outcomes in assisted reproductive cycles (IVF / ICSI)
Public title
The effect of intrauterine injection of human chorionic gonadotropin before embryo transfer on pregnancy outcomes in assisted reproductive cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hip women under the age of 40 who have undergone IVF / ICSI treatment protocols are endocrine candidates for grade A or B embryos.
Exclusion criteria:
Azoospermia through sperm testing
History of uterine surgery through history
Severe endometriosis through history and ultrasound findings
Hydrosalpinx by ultrasound or hysterosalpingography
Endocrine disorders such as diabetes thyroid via blood biochemistry test
History of operative hysteroscopy
History of recurrent miscarriages
More repeated failures equal to 3 times in the history
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After the approval of the ethics committee and performing PCRcovid19 test (due to the unknown nature of Covid virus and its possible effects on fertility results and IVF cycles) from all patients before entering the operating room for embryo transfer "and in case of negative Covid PCR test" women were randomly divided Both groups are assimilated in terms of "BMI" AMH. Speculum is injected and is not injected in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug will be injected in the case group by an infertility specialist and in these cases the patient is unaware of which group he is in, given that the injection is given intrauterine and in a lithotomy position and the patient feels pain during the injection. Will not notice this process, on the other hand, after the embryologist injection, the fetus will be transferred while the patient is in the control group or is unaware of the case.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St., Isfahan University of Medical Sciences and Health Services
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-08-29, 1400/06/07
Ethics committee reference number
IR.MUI.MED.REC.1400.414
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Follicle size
Timepoint
During embryo transfer and one week after embryo transfer
Method of measurement
sonography
2
Description
Type of embryo transferred
Timepoint
---
Method of measurement
--
3
Description
Number of embryos transferred per cycle
Timepoint
Patient cycle
Method of measurement
Laboratory
4
Description
AMH
Timepoint
Before embryo transfer
Method of measurement
Laboratory
Secondary outcomes
1
Description
Ongoing pregnancy
Timepoint
After embryo transfer
Method of measurement
Question from the patient
2
Description
Cilinical pregnancy
Timepoint
After embryo transfer
Method of measurement
Question from the patient
3
Description
Chemical pregnancy
Timepoint
After embryo transfer
Method of measurement
Question from the patient
Intervention groups
1
Description
Intervention group: In the intervention group, a 5000-unit vial of Karma brand with Karma brand is mixed with 0.4 ml of embryo glue and 40 μl of which is equivalent to 500 units of HCG is injected into the uterus through an IUI catheter within 15 minutes before transfer to the erectile position and injected into the orthopedic position.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dr. Beheshti Hospital, Isfahan
Full name of responsible person
Elham Naghshineh
Street address
Felezzy81848 bridge - Ostad Motahhari street
City
Esfahan
Province
Isfehan
Postal code
8184853542
Phone
+98 31 3236 2191
Email
naghshineh@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Naghshineh
Street address
Hezar Jarib St., Isfahan University of Medical Sciences and Health Services
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
naghshineh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Elham Naghshineh
Position
Associate Professor, Gynecologist, Infertility Fellowship, Faculty