Assessment of intrauterine injection of human Chorionic Gonadotropin (hcg) before transferring of Frozen-Thawed embryo on Implantation and clinical pregnancy rate
The main objective of this study is assessment of intrauterine injection of Human Chorionic Gonadotropin (hCG) before transferring of frozen-thawed embryo on implantation and clinical pregnancy rate. This study was performed on patients admitted to Alzahra hospital, Tabriz, Iran. Women younger than 40 years who have frozen embryos are Grade A and B, has been Checked. Patients with a history of uterine surgery, recurrent abortions are excluded. This is a single-blind study. During transfer, patients were randomly divided into two groups, each consisting of 50. In the study group five thousand units of hCG in a vial with 0.4 ml of ISM1 mixed media and 40 microliter of which is equivalent to 500 IU hCG is injected through the catheter into the uterus. Seven minutes after the injection of hCG into the uterus, the fetus in the mother's age and general condition of figure, 2-3 embryos are transferred into the uterus. Abdominal ultrasound-guided embryo transfer catheter sterile ones Labotect, 1-1.5 cm in length is made through the uterine fundus. After embryo transfer, luteal phase support with progesterone vial 100 mg / day IM continues. ΒhCG test two weeks after embryo transfer is requested and if positive early vaginal ultrasound three weeks after embryo transfer. There gestational sac, fetal pole position and number of bags and the heart is examined embryos And progesterone administration continues to eleventh week of pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110612146N5
Registration date:2014-12-04, 1393/09/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-04, 1393/09/13
Registrant information
Name
Laaya Farzadi
Name of organization / entity
Woman's Reproductive Health Research Center of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
farzadl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Expected recruitment start date
2014-11-19, 1393/08/28
Expected recruitment end date
2015-11-17, 1394/08/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of intrauterine injection of human Chorionic Gonadotropin (hcg) before transferring of Frozen-Thawed embryo on Implantation and clinical pregnancy rate
Public title
Assessment of intrauterine injection of human Chorionic Gonadotropin (hcg) before transferring of Frozen-Thawed embryo on Implantation and clinical pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients younger than 40 years old who underwent treatment protocols for IVF (ISCT) however, due to the unsuitable conditions in their endometrium embryo transfer cycles done in fresh or pregnancy occurred; patients with frozen embryos.
Exclusion criteria: patients with a history of uterine surgery; recurrent abortions; hydrosalpinges; endometriosis and endometriomas.
Age
To 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Approval date
2014-10-09, 1393/07/17
Ethics committee reference number
93107
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
Positive Pregnancy Test
Timepoint
Two weeks after embryo transfer
Method of measurement
Test βhCG
Secondary outcomes
1
Description
Gestational sac
Timepoint
Three weeks after embryo transfer
Method of measurement
Primary vaginal ultrasound
2
Description
The number of bags
Timepoint
Three weeks after embryo transfer
Method of measurement
Primary vaginal ultrasound
3
Description
Fetal pole
Timepoint
Three weeks after embryo transfer
Method of measurement
Primary vaginal ultrasound
4
Description
Embryo heart
Timepoint
Three weeks after embryo transfer
Method of measurement
Primary vaginal ultrasound
Intervention groups
1
Description
In the intervention group, five thousand units of hCG in a vial with 0.4 ml of ISM1 mixed media and 40 microliter of which is equivalent to 500 IU hCG injected through the catheter into the uterus. Seven minutes after the injection of hCG into the uterine, depending on the age and general condition of the fetus figure 2-3 embryos are transferred into the uterus.
Category
Treatment - Drugs
2
Description
In the control group, if endometrial thickness to achieve eight millimeters or more injections of progesterone injected intramuscularly at a dose of fifty milligrams per day.Transfer Eight-cell embryo three days after receiving progesterone and received five days after blast cyst transfer is planned.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Farzadi Laya
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzadi Laaya
Position
Associate prof.
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3556 9543
Fax
Email
lahroudin@gmail.com; wrhrcenter@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzadi Laaya
Position
Associate prof.
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3556 9543
Fax
Email
lahroudin@gmail.com; wrhrcenter@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzadi Laaya
Position
Associate prof.
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3556 9543
Fax
Email
lahroudin@gmail.com; wrhrcenter@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)