This study is a parallel randomized clinical trail among infertile patients who refereed to research and clinical center for infertility in yazd and candidate for IVF/ICSI. Controlled ovarian hyper-stimulation done with antagonist protocol.Drug stimulation will be start with Gonal or cinnal from day 2. First sonography for follicular growth assessment done in 7th days of stimulation and then patients monitored every 1-2 days with sonography. when follicular diameter reached 14 mm antagonist drug (cetrotide) will be started.when at least three follicles with average diameter of 18 mm present, estradiol and progesterone level will be measured.If the patient have 7 or less follicles entered to study. Patients divide in two groups with Table of random numbers. Final oocyte maturation with 6500 IU,HCG will done in first group and 6500 IU,HCG and agonist ( triptorelin 0.2)r in second group . Then after 34-36 hours oocyte puncture will be done. We will classify the oocytes maturation based on the morphological appearance. All of retrieved oocytes undergo IVF / ICSI. A maximum of two embryos transfer on day 2 or 3 after oocytes extract. Vaginal progesterone for luteal phase support, start from the day of puncture. Pregnancy test perform Two weeks after the transfer. The main variable is the number of oocytes in metaphase וו. Other variables are , the number of fertilized oocytes (2PN) and the number of embryos formed and chemical and clinical pregnancy rate in each groups. These variables will be compare in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111628756N4
Registration date:2016-12-04, 1395/09/14
Registration timing:prospective
Last update:
Update count:1
Registration date
2016-12-04, 1395/09/14
Registrant information
Name
Elham Naghshineh
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
naghshineh@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2016-12-15, 1395/09/25
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of Dual triggering versus HCG in poor responders in ART outcomes
Public title
A comparison of Dual triggering by administration of GnRH agonist plus HCG versus HCG in poor responders in ART outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Infertile woman who candidate for IVF/ICSI and referred to yazd research and clinical center for infertility and have 7 or less follicles in triggering day
Exclusion criteria:have more than 7 follicles
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
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
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Bouali Avenue, Safayeh,Yazd,Iran
City
Yazd
Postal code
Approval date
2016-09-14, 1395/06/24
Ethics committee reference number
IR.SSU.RSI.REC.1395.18
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin
Primary outcomes
1
Description
Number of metaphase II oocytes
Timepoint
After intervention
Method of measurement
number
Secondary outcomes
1
Description
number of fertilized oocytes (2PN)
Timepoint
after intervention
Method of measurement
number
2
Description
number of emberyo formation
Timepoint
after intervention
Method of measurement
number
3
Description
chemical pregnancy
Timepoint
14 days after transfer
Method of measurement
14 days after transfer
4
Description
clinical pregnancy
Timepoint
28 days after transfer
Method of measurement
28 days after transfer
Intervention groups
1
Description
in intervention group co-administration of HCG and agonist used for triggering
Category
Treatment - Drugs
2
Description
in control group HCG used routinely for triggering
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd research and clinical center for infertility
Full name of responsible person
maryam eftekhar
Street address
booali/safaieh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
reasearch and clinical center for infertility
Full name of responsible person
alimohammad abdoli
Street address
booali/safaieh
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
reasearch and clinical center for infertility
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
research and clinical center for infertility
Full name of responsible person
elham naghshineh
Position
fellowship
Other areas of specialty/work
Street address
booali/safaieh
City
yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
naghshineh@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
maryam eftekhar
Position
associated proffesor
Other areas of specialty/work
Street address
booali/safaieh
City
yazd
Postal code
38247085
Phone
+98 35 3824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
researh and clinical center for infertility
Full name of responsible person
elham naghshineh
Position
followship
Other areas of specialty/work
Street address
booali/safaieh
City
yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
naghshineh@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)