Evaluation effect of intrauterine injection of human chorionc gonadotropin before embryo transfer on implantation rate and pregnancy rate in frozen cycles on IVF/ICSI
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 Novamber 2017through December 2017 we will evaluated 300 patients undergoing IVF/ICSI at our center for treatment of infertility . Patients will be divided into tow 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, 10,000IU 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, injecting HCG intrauterine, Culture media will added to a vial HCG 500IU and will be get HCG dilution requirement(500IU 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 500IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 10 minutes 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:IRCT2017041733486N1
Registration date:2017-10-13, 1396/07/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-13, 1396/07/21
Registrant information
Name
Zohreh Ziaee
Name of organization / entity
Tehran university
Country
Iran (Islamic Republic of)
Phone
+98 21 2205 0129
Email address
ziaee-z@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor Of Research, Tehran University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of intrauterine injection of human chorionc gonadotropin before embryo transfer on implantation rate and pregnancy rate in frozen cycles on IVF/ICSI
Public title
Evaluation effect of human chorionic gonadotropin on pregnancy outcome in infertile patients
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria:patients with a history of utrine surgery such as myomectmy;Patients with a history of recurrent miscarriage;Patients with known hydrosalpinx;Patients with endometriosis and endometroma;Patients with history of RIF(>3);Patients >40 years ;Inclusion criteria:All patients under age 40 years who refer to Omid fertility centre and shariati hospital who suffered from infertility.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Number21, Daneshgah St, Valiasr Ave, Tehran, Iran
City
Tehran
Postal code
1416753955
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1660
Health conditions studied
1
Description of health condition studied
IVF
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization Admission for harvesting or implantation of ova
2
Description of health condition studied
ICSI
ICD-10 code
Z31.1
ICD-10 code description
Artificial insemination
3
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
Embryo implantation
Timepoint
4 weeks after transfer
Method of measurement
Sonography
2
Description
chemical pregnancy
Timepoint
2 weeks after transfer
Method of measurement
pregnancy test(BHCG test)
3
Description
clinical pregnancy
Timepoint
4-5 weeks after emberyo transfer
Method of measurement
observation of fetal heart activity by transvaginal ultrasonography
Secondary outcomes
1
Description
Abortion
Timepoint
2-4 weeks after transfer
Method of measurement
By sonography,clincal finding, pregnancy test
2
Description
ectopic pregnancy
Timepoint
4weeks after transfer
Method of measurement
by sonography ,pregnancy test
Intervention groups
1
Description
Control group:
The second group (n 130) did not receive the administration of 500 IUhCG.
Category
Other
2
Description
Interventional group (n 130) was injected with 500 UI of intrauterine hCG before embryo transfer.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Ziaee Zohreh OB/GYN Resident
Street address
Shariati Hospital,North KargarSt.Tehran.Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Omid Fertility Clinic
Full name of responsible person
Ziaee Zohreh OB/GYN Resident
Street address
Number2, Dead end bazargan, Shahbaznejad Alley, Aghaee St, Niavaran Ave, Tehran,Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research,Tehran University of Medical Sciences
Full name of responsible person
Mrs Kermani
Street address
Number21,Daneshgah st,Valli-e asr ave ,Tehran,Iran
City
Tehran
Grant name
None
Grant code / Reference number
None
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research,Tehran 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
Tehran University
Full name of responsible person
Ziaee Zohreh
Position
OB/GYN Residency
Other areas of specialty/work
Street address
Number21,Dneshgah St,Valli-e Asr Ave,Tehran,Iran
City
Tehran
Postal code
1416753955
Phone
+98 21 8889 6692
Fax
+98 21889522654
Email
ziaee-z@razi.tums.c.ir
Web page address
www.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University
Full name of responsible person
Ziaee Zohreh
Position
OB/GYN residency
Other areas of specialty/work
Street address
Number21,Daneshghah St,Valli-eAsr Ave,Tehran,Iran
City
Tehran
Postal code
14167533955
Phone
+98 21 8889 6692
Fax
+98 21 8885 2654
Email
ziaee-z@razi.tums.ac.ir
Web page address
www.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University
Full name of responsible person
Ziaee Zohreh
Position
OB/GYN Residency
Other areas of specialty/work
Street address
Number21,Daneshgah St,Valli-e Asr Ave,Tehran,Iran
City
Tehran
Postal code
1416753955
Phone
+98 21 8889 6692
Fax
+98 21888522654
Email
ziaee-z@razi.tums.ac.ir
Web page address
www.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)