Comparison administration single dose GNRH agonist(Triptrolin) with placebo in the luteal phase on clinical pregnancy rate in ART cycle in the infertile women.
Randomized double blind clinical trial .single center to evaluate effect of single dose GnRH agonist(Triptrolin 0.1 mg) for luteal phase support on the probability of clinical pregnancy rates in ART cycle.328 women who were referred to Omid clinic in 2014,divided into a luteal-phase triptrolin and placebo group by means of computer generated randomization program.Patients received either GnRH agonist(long protocol)or GnRH antagonist protocol. For agonist group,daily injection of Buserlin 0.5 mg subcutaneous (sc) started on the 21st day of preceding cycle.The dose was reduced to 0.25mg/day on commencement of menstrual bleeding.Gonadotropin stimulating hormone(rFSH or HMG) started on the second day of menstrual bleeding to control ovarian stimulation, Dose ranged between 150 -450 IU.Administration of drugs continued till 3 follicles with 18 mm. Patients who received antagonist protocol,Gonadotropin stimulating hormone(rFSH or HMG) started on the second day and continued till the size of follicles became 14 mm,then GnRH antagonist( Cetrotide, 0.25mg, sc) was started and continued till three follicles reached 18mm.then 10000 IU hcg(human chorionic gonadotropin )intramuscular administered. Ovum retrieval was undertaken 36 h after hcg administered under sonographic guide with 17 guage needle.embryo transfer(ET) was performed on day 2 or 3 after ovum retrieval.Three days after ET ,0.1 mg triptrolin was injected for patients in intervention group and normal saline injection in control group.For all cases progestrone was administered after ovum retrieval till fetus cardiac activity detected.clinical pregnancy was identified by development of a gestational sac. Secondary consequence ,was increased implantation rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030916912N1
Registration date:2014-06-26, 1393/04/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-26, 1393/04/05
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
Tehran University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2014-08-21, 1393/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison administration single dose GNRH agonist(Triptrolin) with placebo in the luteal phase on clinical pregnancy rate in ART cycle in the infertile women.
Public title
Effect of administration GNRH agonist(Triptrolin) on clinical pregnancy in ART
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:
328
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
Ghods street,Keshavarz avenue, university central organization.sixth floor
City
Tehran
Postal code
Approval date
2014-03-12, 1392/12/21
Ethics committee reference number
92/د/130/2996
Health conditions studied
1
Description of health condition studied
INFERTILITY
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male factors
Primary outcomes
1
Description
clinical pregnancy
Timepoint
eight week after intervention
Method of measurement
vaginal sonography
Secondary outcomes
1
Description
Implantation rate
Timepoint
Ten week after intervention
Method of measurement
vaginal sonography
Intervention groups
1
Description
Three days after embryo transfer ,0.1 mg(1ml) triptrolin subcutaneous was injected for patients in intervention group.
Category
Treatment - Drugs
2
Description
Patients in control group received 1ml normal saline subcutaneous injection three days after embryo transfer.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shariati hospital
Full name of responsible person
saeedeh gharahjeh
Street address
Jalal al ahmad avenue
City
Tehrah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research , Tehran University of Medical Sceince
Full name of responsible person
Dr Akbar Fotouhi
Street address
16 Azar avenue, Keshavarz Boulevard, Tehran University of Medical Scince
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 Sceince