Evaluation effect of intrauterine human chorionic gonadotropin injection before embryo transfer in implantation and pregnancy rate in infertile patients and comparison with conventional embryo transfer in IVF/ICSI/ET cycles
The aim of this study will be to investigate the value of intrauterine HCG injection before embryos transfer in improvement of implantation and pregnancy rates in cycles of
IVF/ ICSI. From April 2012 through March 2014 we will evaluated 159 patients undergoing IVF/ICSI at our center for treatment of infertility .
Patients will be divided into three groups using a random numbers table. In all patients in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Embryo transfer (ET) will be performed48-72 hours after. In the study groups, two groups of injecting HCG intrauterine, Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(1000 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS, 40 microliter of tissue culture medium containing 1000 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. In the control group, ET will performed without the intrauterine hCG injection.In control group between 2-3 embryo through of Cook catheter embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used .
primary outcomes: Chemical pregnancy, Clinical pregnancy , Implantation rates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091310328N3
Registration date:2013-01-12, 1391/10/23
Registration timing:registered_while_recruiting
Last update:
Update count:2
Registration date
2013-01-12, 1391/10/23
Registrant information
Name
Sima Janati
Name of organization / entity
Research and Clinical Center for Infertility, Dezful University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 9781
Email address
janati@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Clinical Center for Infertility, Shahid sadoughi university of medical sciences, Yazd
Expected recruitment start date
2012-04-05, 1391/01/17
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of intrauterine human chorionic gonadotropin injection before embryo transfer in implantation and pregnancy rate in infertile patients and comparison with conventional embryo transfer in IVF/ICSI/ET cycles
Public title
Evaluation effect of human chorionic gonadotropin on pregnancy outcome in infertile patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : female
Exclusion criteria:age more than 40 and below than 20 years old; FSH more than 12; Infertility causes except male or unexplained factor infertility; azoospermia ; presence of uterine myoma ; endometriosis ; hydrosalpinges; previous IVF/ICSI trials( successful or unsuccessful); history of endocrine diseases for example diabetes or thyroid dysfunction; patients with previous history of hysterocopic operation due to submoucosal myoma or intrauterine synechia.
.
Age
From 20 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
159
Randomization (investigator's opinion)
N/A
Randomization description
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
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd
Street address
Bouali Ave, Safayeh, Research and Clinical Center for Infertility, Yazd
City
Yazd
Postal code
Approval date
2012-03-15, 1390/12/25
Ethics committee reference number
3771
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfe
Primary outcomes
1
Description
Implantation rate
Timepoint
4 weeks after embryo transfer
Method of measurement
Observation of number of gestational sacs by transvaginal ultrasonography per 100 embryo transfer
2
Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
BHCG test
3
Description
Clinical pregnancy
Timepoint
4 -5 weeks after embryo transfer
Method of measurement
observation of fetal heart activity by transvaginal ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
In control group (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed and 48-72 hours after between 2-3 embryo through of Cook catheter embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used .
Category
Treatment - Drugs
2
Description
In group 1 intervention (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(500 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS , 40 microliter of tissue culture medium containing 500 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used .
Category
Treatment - Drugs
3
Description
In group 2 intervention (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(1000 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS, 40 microliter of tissue culture medium containing 1000 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science ,Yazd
Full name of responsible person
Dr.Sima Janati
Street address
Boali Ave, Safayeh , Research and Clinical Center for Infertility,Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente
Full name of responsible person
Dr. Razieh Dehghani Firouzabadi
Street address
Bouali Ave,Safayeh, Research and Clinical Center for Infertility, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente
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
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd
Full name of responsible person
Dr.Sima Janati
Position
Assisted Professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Other areas of specialty/work
Street address
Bouali Ave, Safayeh, Research and Clinical Center for Infertility, Yazd
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
janati@dums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd
Full name of responsible person
Dr.Razieh Dehghani Firouzabadi
Position
Associate professor of Obstetrics and Gynecology, fellow ship of infertility
Other areas of specialty/work
Street address
Bouali Ave, Safayeh، Research and Clinical Center for Infertility, Yazd
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
dr-firouzabadi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd
Full name of responsible person
Dr. Sima Janati
Position
Assisted professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Other areas of specialty/work
Street address
Bouali Ave, Safayeh, Research and Clinical Center for Infertility, Yazd
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
janati@dums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)