Evaluation the effects of intrauterine Human Chorionic Gonadotropin injection on intracytoplasmic sperm injection –Embryo transfer cycles success rates.
Objective: To investigate the effect of intrauterine injection of human chorionic gonadotrophin on the day of oocyte recovery on clinical pregnancy and implantation rates in intracytoplasmic sperm injection-embryo transfer cycles.
Design: Clinical terial.
Setting and conduction: : Infertility & Reproductive Health Research Centre, Shahid Beheshti University of Medical Science, Thaleghani hospital.
Participant(s): 308 infertile women who attending in the private infertility clinic, Tehran, That have aged 20-40 years undergoing fresh intracytoplasmic sperm injection-embryo transfer cycles and have normal endometrial thickness (7-12 milimeters) on the day of embryo transfer and thay dont have any visible endometrial pathology, And they have less than three failed previous intracytoplasmic sperm injection cycles, BMI <30, And duration of infertility less than 10 years are included. And randomly divided in two groups.
Intervention: In case group 5000 IU/ml of urinary human chorionic gonadotrophin diluted with with 1 ml of media and immedietly after oocyte recovery, Injected in to the uterine cavity by IUI catheter and three days later embryo transfered. But in the control group continues treatment without any intervention .
Main outcome mesure: Clinical pregnancy rates, Implantation rates.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014122320408N1
Registration date:2015-01-18, 1393/10/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-18, 1393/10/28
Registrant information
Name
Robabeh Taheripanah
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2558
Email address
taheripanahf@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Infertility & Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of intrauterine Human Chorionic Gonadotropin injection on intracytoplasmic sperm injection –Embryo transfer cycles success rates.
Public title
Effect of HCG on pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women aged 20-40 years undergoing fresh intracytoplasmic sperm injection -embryo transfer cycles that have normal endometrial thickness (7-12 milimeters) on the day of embryo transfer and thay dont have any visible endometrial pathology, And they have less than three failed previous intracytoplasmic sperm injection cycles, BMI <30, And duration of infertility less than 10 years are included.
Exclusion criteria: Abnormally shaped uterus in hysterosalpingography or hysteroscopy, More than 3 previous failure of intracytoplasmic sperm injection-embryo transfer cycles, BMI> 30, And duration of infertility is more than 10 years and severe male infertility.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
308
Randomization (investigator's opinion)
Randomized
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
Infertility & Reproductive Health Research Center Ethics committee of Shahid Beheshti University of
Intervention: In case group 5000 IU/ml of urinary human chorionic gonadotrophin diluted with with 1 ml of media and immedietly after oocyte recovery, Injected in to the uterine cavity by IUI catheter and three days later embryo transfered.
Category
Treatment - Drugs
2
Description
Control group: Continues treatment without any intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
IVF ward, Parsian hospital
Full name of responsible person
Marzieh Zamanian
Street address
Taleghani hospital, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Infertility & Reproductive Health Research Center of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sadeghzade
Street address
Taleghani hospital, IVF ward, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Infertility & Reproductive Health Research Center of Shahid Beheshti 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
Infertility & Reproductive Health Research Center Shahid Beheshti University of Medical Science
Full name of responsible person
Robabeh Taheripanah
Position
Associate professor
Other areas of specialty/work
Street address
IVF ward,Taleghani Hospital, Velenjak, Shahid Chamran higway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 5530 1452
Fax
+98 21 2243 2600
Email
taheripanahf@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infertility & Reproductive Health Research Centre - Shahid Beheshti of Medical Science
Full name of responsible person
Marzieh Zamaniyan
Position
Obstetric and gynecologist
Other areas of specialty/work
Street address
IVF ward, Taleghani Hospital, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 5530 1452
Fax
+98 21 2243 2600
Email
marziehzamaniyan@gmail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Infertility & Reproductive Health Research Centre - Shahid Beheshti of Medical Science
Full name of responsible person
Marzieh zamaniyan
Position
Obstetric and gynecologist
Other areas of specialty/work
Street address
IVF ward, Taleghani Hospital, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 5530 1452
Fax
+98 21 2243 2600
Email
marziehzamaniyan@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)