compairig the efficacy of intramuscular injection of HCG(human chorionic gonadotropin )before embryo transfer versus intrauterine injection with control group on clinical pregnancy in infertile women canditate for ART (Assisted Reproductive Technology)cycle
Objective: to evaluate effect of hcg for luteal phase support on increasing the probability of clinical pregnancy rates in ART cycles. Design: Randomized double blind clinical trial single center Setting and conduct: 300 women refered to Shariati hospital in 2014, will be divided into three groups by means of computer generated randomization program. Intervention: Patients will receive either GnRH agonist(long protocol)or GnRH antagonist protocol. For agonist group, daily injection of Buserlin 0.5 mg subcutaneous (sc) will start on the 21st day of preceding cycle. The dose will reduce to 0.25mg on commencement of menstrual bleeding. Gonadotropin stimulating hormone(rFSH or HMG) will start on the second day of menstrual bleeding to control ovarian stimulation, dose range between 150 -450 IU. Administration of drugs will continue till 3 follicles with 18 mm. Patients who receive antagonist protocol, rFSH or HMG will start on the second day and continue till the size of follicles become 14 mm, then GnRH antagonist(Cetrotide, 0.25mg, sc) will start and continue till three follicles will reach 18mm. then 10000 IU hcg (human chorionic gonadotropin )intramuscular will administer. Ovum retrieval will undertake 36 h after hcg administeration, under sonographic guide with 17 guage needle. embryo transfer(ET) will perform on day 2 or 3 after ovum retrieval.on days of ET, 1500 IU hcg will inject for patients in one group and 500 IU hcg intrauterine will inject before ET in another group with control group . Main outcome measures variables: clinical pregnancy will be identified by development of a gestational sac. Secondary consequence: increased implantation rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050316912N2
Registration date:2014-11-23, 1393/09/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-23, 1393/09/02
Registrant information
Name
Saeedeh Gharahjeh
Name of organization / entity
ٰTehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8873 6218
Email address
s-gharahgeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sceinces
Expected recruitment start date
2014-08-11, 1393/05/20
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
compairig the efficacy of intramuscular injection of HCG(human chorionic gonadotropin )before embryo transfer versus intrauterine injection with control group on clinical pregnancy in infertile women canditate for ART (Assisted Reproductive Technology)cycle
Public title
Effect of HCG (human chorionic gonadotropin) injection on clinical pregnancy in ART (Assisted Reproductive Technology) cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: couples undergoing ART with their own gametes; good and high responder women; women age less than 40, FSH level less than 10 mIU/ml on third day of mense, AMH more than 1.1 ng/ml; couples having at least one embryo available for transfer. Exclusion criteria: couples undergoing ART with donation gamate; azospermia; poor responder women: women age more than 40, FSH level more than 10 mIU/ml on third day of mense, AMH less than 1.1 ng/ml and less than 4 f0llicles in previous ART cycle.
Age
From 16 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Medical ethics committee, sixth floor, university central organization, Ghods street,Keshavarz avenue
City
Tehran
Postal code
14114
Approval date
2014-08-10, 1393/05/19
Ethics committee reference number
93/ص/130/985
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97.4
ICD-10 code description
female infertility associated with male factor
Primary outcomes
1
Description
clinical pregnancy
Timepoint
eight weeks after intervention
Method of measurement
vaginal sonography
Secondary outcomes
1
Description
Implantation rate
Timepoint
Ten weeks after intervention
Method of measurement
vaginal sonography
Intervention groups
1
Description
The day of embryo transfer, 1500 IU hcG (human chorionic gonadotropin) will be injected intermuscular in one group
Category
Treatment - Drugs
2
Description
The day of embryo transfer, 500 IU hcG (human chorionic gonadotropin) will be injected 7 minutes before embryo transfer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shariati Hospital
Full name of responsible person
Saeedeh Gharahjeh
Street address
Infertility department, second floor, Shariati Hospital, Jalal al ahmad avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research , Tehran University of Medical Sceinces
Full name of responsible person
Dr Akbar Fotouhi
Street address
Vice Chancellor for Research, Second floor, Tehran University of Medical Sciences, 16 Azar Avenue, Keshavarz Boulevard
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 Sceinces
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
Saeedeh Gharahjeh
Position
Infertility Fellowship
Other areas of specialty/work
Street address
Infertility department, Second floor, Shariati Hospital, Jalal al ahmad avenue