The main aim of this study is comparing the efficiency of two types of short Triptorlin treatment protocols with conventional long antagonist protocols in micro-injection infertile candid patients.
This study is a triple blind(doctor, patient and infertility counselor), choosing 150 patients including (healthy women between “18 – 40”) and excluding from study (PCOs women) randomly dividing to 3 groups 50 each. Control group (conventional long protocol): for down regulation, Triptorlin begins from 21st day of menstrual cycle with 0.1 dosage and continues till HCG injection day. Gonadotropin usage begins from 2-3 days menstrual cycle and continues till observing an 18 mm >follicle and HCG injection. Intervening group 1: Triptorlin begins from 21st day of menstrual cycle with 0.1 dosages and will end from 4th day of Genadotropin injection. Intervening group 2: Triptolin begins from 21st day of menstrual cycle and will end at the first day of Gonadotropin injection. At last ongoing pregnancy rate, number of embryos, number of good quality embryos, quantity of in-vitro fertilization, ET, the abortion rate, will be comparatively examine at three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310311760N26
Registration date:2014-08-02, 1393/05/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-02, 1393/05/11
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Babol University of Medical Sciences
Expected recruitment start date
2014-05-15, 1393/02/25
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficiency of two short- term agonist protocols with conventional long protocol in women candidate Microinjection
Public title
Comparison of the efficiency of two short- term agonist protocols with conventional long protocol in women candidate Microinjection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusio criteria:
Healthy women 18 to 40 years; BMI = 20-32; Regular menstrual
Exclusion criteria:
Women PCOs; thyroid disorders, severe endometriosis, those with ovarian or uterine and ovarian pathology; FSH> 15 IU / LI on day 3 of the cycle; POOR RESPONSE; history of hyper stimulation in previous cycles; smokers; Abnormalities of the uterus, ovary-stimulating drugs or diet 2 months ago or the diet
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Babol University of Medical sciences
Street address
Ganjafroz Avenue, Babol University of Medical sciences
City
Babol
Postal code
Approval date
2014-04-23, 1393/02/03
Ethics committee reference number
4018/30/پ
Health conditions studied
1
Description of health condition studied
Female infertility associated with male factors
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male factors
Primary outcomes
1
Description
Pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
Laboratory
Secondary outcomes
1
Description
The number of embryos
Timepoint
14 the next day embryo transfer
Method of measurement
Ultrasound
2
Description
The number of high quality embryos
Timepoint
14 the next day embryo transfer
Method of measurement
Ultrasound
3
Description
Total fertility/ET
Timepoint
14 the next day embryo transfer
Method of measurement
Ultrasound
4
Description
The number of abortions performed
Timepoint
After 10 weeks of gestational sac formation
Method of measurement
clinical
5
Description
Consists of dominant follicles
Timepoint
12 -16 day cycle
Method of measurement
Ultrasound
6
Description
Of the ampoules used per protocol
Timepoint
Duration of treatment
Method of measurement
clinical
Intervention groups
1
Description
Control Groups:
Standard protocol, for Down regulation, Triptorelin dose of 0.1 (to SC) from day 21 of the cycle begins.Continues until the day of HCG injection. Gonadotropins for stimulate ovulation cycle is 2-3 days and begin to see at least one follicle> 18mm and HCG injection continues.
Category
Treatment - Drugs
2
Description
Intervention Group1:
Triptorelin dose of 0.1 (to SC) from day 21 of the cycle begins. Four day, gonadotropin injection stops.
Category
Treatment - Drugs
3
Description
Intervention Group2:
Triptorelin dose of 0.1 (to SC) from day 21 of the cycle begins. First day, gonadotropin injection stops.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemehzahra Fertility & infertility hospital
Full name of responsible person
Dr. Poope A Rezaeian
Street address
Fatemeh-zahra Infertility and Reproductive Health Research Center,Old Road, Amol, Babol, After Mohammad Hassan Khan Bridge
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Ganjafroz Avenue, Babol University of Medical sciences
City
Babol
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,Babol 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
Fatemehzahra Infertility & reproductive Health Reseach Center
Full name of responsible person
Dr. Poope A Rezaeian
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Fatemeh-zahra Infertility and Reproductive Health Research Center,Old Road, Amol, Babol, After Mohammad Hassan Khan Bridge
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
persia_ph@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemehzahra Infertility & reproductive Health Reseach Center
Full name of responsible person
Dr. seddigheh Esmaeilzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemeh-zahra Infertility and Reproductive Health Research Center,Old Road, Amol, Babol, After Mohammad Hassan Khan Bridge
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
sesmael@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Nargess Gholizadeh Pasha
Position
MAc
Other areas of specialty/work
Street address
City
Babol
Postal code
Phone
00
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)