the aim of this study :evaluation of dual-trigger effect on oocyte quality in comparison with HCG-trigger
study design:Randomized Controledl Trial,two centers,prospective,on infertile women ages between 18-40,with normal ovarian response,
Inclusion criteria:regular mense;BMI=18-35;FSH days3<10
Exclusion criteria:FSH days 3>=10;AMH=<1.1; expectancy for ovarian hyper response;endocrine deases(DM ,..);uterine anomaly in HSG or hysteroscopy;sever male factor;history of OHSS;criteria of ovarian hyper response or ovarian poor response
sample size:126 infertile women
Intervention: in IVF cycle for final oocyte maturation routinely used of 10000 IU HCG(in our study in control group patient will receive this dosage of drug ) ,in intervention group we will use of 5000 IU HCG with 0.2 mg decapeptyl(GNRH -agonist)
this intervention will be done on the day of HCG trigger
our goals:evaluation of this intervention on total oocyte number ,number of oocyte Metaphase II ,total number of embryos ,pregnancy rate ,rate of OHSS
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061722795N1
Registration date:2016-02-01, 1394/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-01, 1394/11/12
Registrant information
Name
Marzieh Ghasemi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5581
Email address
drghasemi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
we don`t need to funding source
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of dual- trigger and HCG-trigger on final oocyte maturation in infertile patients with ovarian normal response
Public title
Comparison of dualL-Trigger and hcg-Trigger on infertile patients with normal ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
age18-40 years;regular mense(25-34 days);BMI between 18-35;FSH days 3 <10
exclusion criteria:
FSH days 3 >=10;AMH=<1.1;expectancy for ovarian hyper response(>=16 follicles on the last trans vaginal sonography );endocrine deases(DM ,hyperprolactinemia,thyroide dysfunction ,CAH,cushing syndrome);PCOs;uterine anomaly in HSG or hysteroscopy;sever male factor(azospermia require to TESE or PESA);history of OHSS;criteria of ovarian hyper response or ovarian poor response
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:
126
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
Tehran University of Medical Sciences
Street address
central building of Tehran University of Medical Sciences ,keshavarz BLV,Tehran,Iran
City
Tehran
Postal code
1417614411
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.TUMS.REC.1394.1578
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97.0,N97.
ICD-10 code description
Female infertility associated with anovulation,Female infertility of tubal origin,Female infertility associated with male factors,Female infertility of other origin,Female infertility, unspecified,
Primary outcomes
1
Description
Number of Metaphase II oocyte
Timepoint
on oocyte retrieval day
Method of measurement
evaluation by embryologist under microscope
2
Description
number of Metaphase II oocytse ,total number of oocytes,number of embryoss
Timepoint
oocyte retrieval day,day3 after oocyte retrieval or IVF
Method of measurement
evaluation under microscope by an embryologist and scoring by scientific evidence