The effect of intrauterine administration of human chorionic gonadotropin after oocyte pick up on the outcome of intracytoplasmic sperm injection and embryo transfer (ICSI/ET) in infertile couples
The aim of this study is to evaluate the effect of intrauterine injection of human chorionic gonadotropin after oocyte pick up on the outcome of intracytoplasmic sperm injection and embryo transfer (ICSI/ET) in infertile couples. Inclusion criteria are: eighteen to forty years old women candidate of intracytoplasmic sperm injection and embryo transfer (ICSI/ET); normal TSH; normal PRL; normal AMH or day 2 to 4 FSH and E2. Exclusion criteria are: Uncontrolled chronic maternal disease like endocrinopathy and autoimmune disease; endometriosis; severe hydrosalpinx; azospermia; oocyte donation; when it is required to do a surgical operation after oocyte pick up and before embryo transfer or for any reason the embryo transfer must be deferred; high risk of OHSS; morphologic embryo deficiencies. These women will be treated with the antagonist protocol for controlled ovarian stimulation and when at least 3 or more follicle with diameter of 17 mm or more is detected by transvaginal ultrasonography, the last trigger for ovulation will be induced with intramuscular injection of 10000 unit of human chorionic gonadotropin (HSG). Thirty six to 40 hours later they will be picked up their oocytes under general anesthesia. These women will have been divided randomly in two groups. The person who prepares the drug for injection will be the only person who is informed from the allocation of the patient. Immediately after oocyte pick up, the patients in the study and control groups will receive intrauterine 500 unit of HSG in up to 0.5 cc of normal saline or 0.5 cc of normal saline through intrauterine insemination (IUI) catheter with insulin syringe, respectively. Fresh embryo transfer will be take place in third or fourth day. The rate of implantation, intrauterine pregnancy, abortion, ectopic pregnancy, OHSS will be compared between the two groups.
General information
Acronym
_
IRCT registration information
IRCT registration number:IRCT201206165485N4
Registration date:2015-09-02, 1394/06/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-02, 1394/06/11
Registrant information
Name
Nazli Navali
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Medecine
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 2879
Email address
navalin@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Women's Reproductive Health Research Center, Tabriz University of Medical Scienses
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intrauterine administration of human chorionic gonadotropin after oocyte pick up on the outcome of intracytoplasmic sperm injection and embryo transfer (ICSI/ET) in infertile couples
Public title
The effect of intrauterine administration of human chorionic gonadotropin after oocyte pick up on the outcome of intracytoplasmic sperm injection and embryo transfer (ICSI/ET) in infertile couples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Eighteen to forty years old women candidate of intracytoplasmic sperm injection and embryo transfer (ICSI/ET); normal TSH; normal PRL; normal AMH or day 2 to 4 FSH and E2
Exclusion criteria: Uncontrolled chronic maternal disease like endocrinopathy and autoimmune disease; endometriosis; severe hydrosalpinx; azospermia; oocyte donation; when it is required to do a surgical operation after oocyte pick up and before embryo transfer or for any reason the embryo transfer must be deferred; high risk of OHSS; morphologic embryo deficiencies
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research Deputy of Tabriz University of Medical Sciences, University of Tabriz, Golgasht street
City
Tabriz
Postal code
Approval date
2015-06-18, 1394/03/28
Ethics committee reference number
5/4/3129
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
implantation rate
Timepoint
two weeks after embryo transfer
Method of measurement
beta HCG titrating
2
Description
pregnancy rate
Timepoint
3weeks after embryo transfer
Method of measurement
ultrasonography
3
Description
heart rate detection
Timepoint
4weeks after embryo transfer
Method of measurement
ultrasonography
Secondary outcomes
1
Description
ectopic pregnancy rate, abortion rate
Timepoint
four weeks after embryo transfer
Method of measurement
beta HCG titrating, ultrasonography
2
Description
ovarian hyperstimulation rate
Timepoint
1week after transfer
Method of measurement
sign and symptoms
Intervention groups
1
Description
Intervention group 1: immediately after oocyte pick up, the patients in the study group will receive intrauterine 500 unit of human chorionic gonadotropin (HSG) with trade mark of Choriomon (IBSA) in up to 0.5 cc of normal saline through cervical canal after passing the internal os, by intrauterine insemination (IUI) catheter and insulin syringe. Then the women will rest for 10 minutes.
Category
Treatment - Drugs
2
Description
Control group: Immediately after oocyte pick up, the patients in the control group will receive 0.5 cc of normal saline through cervical canal after passing the internal os, by intrauterine insemination (IUI) catheter and insulin syringe. Then the women will rest for 10 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Nazli Navali
Street address
Artesh street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Women's Reproductive Health Research Center, Vice chancellor for research, Tabriz University of Med
Full name of responsible person
dr.Elahe Saheb Olad Madarec
Street address
Artesh street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Women's Reproductive Health Research Center, Vice chancellor for research, Tabriz University of Med
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
Nazli Navali
Position
infertility fellowship/associate professor
Other areas of specialty/work
Street address
Artesh street, Alzahra Hospita, infertility department
City
Tabriz
Postal code
5138665793
Phone
+98 41 3554 1221
Fax
Email
navalin@tbzmed.ac.ir
Web page address
http://alzahrahosp.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
نازلی نوالی
Position
associate professor/infertility fellowship
Other areas of specialty/work
Street address
Infertility department, Alzahra Hospital, Artesh street
City
Tabriz
Postal code
5138665793
Phone
+98 41 3554 1221
Fax
Email
navalin@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
associate professor/infertility fellowship
Other areas of specialty/work
Street address
Infertility department, Alzahra Hospital, Artesh street
City
Tabriz
Postal code
5138665793
Phone
+98 41 3554 1221
Fax
Email
navalin@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)