Comparsion of the effect of intra uterine injection of human chorionic gonadotropin through soft catheter in time of embryo transfer and no injection in infertile women candidate of in vitro fertilization.
This study is doing with purpose of comparsion of the effect of intrauterine injection of human chorionic gonadotropin through soft catheter in time of embryo transfer and no injection in infertile women candidate of in vitro fertilization and intra cytoplasmic sperm injection. Inclusion criteria in study is the women with infertility male factor and exclusion criteria from study is age above 40 years old; Doing previous in vitro fertilization and intra cytoplasmic sperm injection with one successful case; uterine myoma; pervious myomectomy; endometriosis; hydrosalpanx. This study has done on 300 patients refer to infertility clinic Jameh Zanan Hospital that divide in two groups case and control randomly. In case group inject 500 unit(1 cc) human chorionic gonadotropin only once intrauterine through soft catheter in time of embryo transfer and in control group do not inject any drug after embryo transfer. finally after 14 days pregnancy will compare in two group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110815320N1
Registration date:2014-03-15, 1392/12/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-15, 1392/12/24
Registrant information
Name
Samaneh Jalali
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2270 5137
Email address
s-jalali@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Reserch, Tehran University of Medical Sciences
Expected recruitment start date
2013-11-18, 1392/08/27
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
Comparsion of the effect of intra uterine injection of human chorionic gonadotropin through soft catheter in time of embryo transfer and no injection in infertile women candidate of in vitro fertilization.
Public title
The study of the effect of intrauterine injection of human chorionic gonadotropin to increase of pregnancy rate in result of in vitro fertilization.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women with infertility male factor.
Exclusion criteria: Women above 40 years old;Previous IVF/ICSI with one successful case; Uterin myoma;Previous myomectomy;Endometriosis; Hydrosalpanx.
Age
From 15 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research Tehran University of Medical Sciences
Street address
Northern door of university, Poorsina avenue, Ghods avenue, Enghelab street.
City
Tehran
Postal code
Approval date
2013-10-29, 1392/08/07
Ethics committee reference number
130/1639/د/92
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N-97
ICD-10 code description
Inability to achieve a pregnancy sterility femal NOS
Primary outcomes
1
Description
Pregnancy rate.
Timepoint
Two weeks after embryo transfer.
Method of measurement
Measurement of serum BHCG according to miu/ml.
2
Description
Fetal Implantation
Timepoint
Five weeks after embryo transfer.
Method of measurement
Uterine sonography
Secondary outcomes
1
Description
Miscarriage rate
Timepoint
Twentieth weeks of pregnancy
Method of measurement
Uterine sonography
Intervention groups
1
Description
The injection of 500 unit (1cc )human chorionic gonadotropin intrauterine through soft catheter once in time of embryo transfer in case group.
Category
Treatment - Other
2
Description
Do not injection any drug in control group only enter the injection instrument (soft catheter).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Jameh Zanan Hospital Infertility Clinic
Full name of responsible person
Doctor Ozra Azmoodeh Fellowship Gynocology and Infertility Assistant professor
Street address
Jame zanan hospital, Northern nejatollahi avenue, Karimkhan zand street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Tehran University of Medical Sciences
Full name of responsible person
Doctor Akhoondzadeh
Street address
Northen door of university, Poorsina avenue, Ghods avenue, Enghelab street.
City
Tehran
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 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 of Medical Sciences
Full name of responsible person
Samaneh Jalali
Position
Doctor/Gynocology and Obstetric Resident
Other areas of specialty/work
Street address
Northern door of university, Poorsina avenue, Ghods avenue, Enghelab street.
City
Tehran
Postal code
Phone
+98 218890002
Fax
Email
j.sama5920@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ozra Azmoodeh
Position
Assistant professor
Other areas of specialty/work
Street address
Northern door of university, Poorsina avenue, Ghods avenue, Enghelab street.
City
Tehran
Postal code
Phone
+98 21 8890 0002
Fax
Email
medicin.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Jalali
Position
Doctor/Gynocology and Obstetric Resident
Other areas of specialty/work
Street address
Northern door of university, Poorsina avenue, Ghods avenue, Enghelab street.
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)