Comparison of Long and Agonist-Antagonist protocols for ovarian stimulation in normal responder patients undergoing Intra Cytoplasmic Sperm Injection .
Randomized clinical trial. Under study population: Infertile normal responder patients referred to infertility clinic for ovarian stimulation under treatment of ICSI.
Inclusion criteria: normal responder; BMI less than 30 . Exclusion criteria: low responder; high responder patients.
In this study patients divided into two groups: In one group patients treating with Long protocol and other group treating with Agonist-Antagonist protocol. Sixty patients are in each group. After IVF, the results checked in short time and long time and effectiveness of these two protocol checked in clinical and chemical pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022326711N1
Registration date:2016-04-11, 1395/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-11, 1395/01/23
Registrant information
Name
fateme fakhar moghadam
Name of organization / entity
tehran university
Country
Iran (Islamic Republic of)
Phone
+98 21 3307 4689
Email address
aghahoseini@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-01-14, 1394/10/24
Expected recruitment end date
2016-05-13, 1395/02/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Long protocol And Agonist-Antagonist protocol in the infertile normal responder patients undergoing ICSI cycles
Public title
Comparison of Long protocol And Agonist-Antagonist protocol in the infertile normal responder patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: normal responder infertile patients included (It means age less than 40 and normal ovarian reserve( 6<AFC<12 ) accompanying with 3.5>AMH>1); also patients had good response to previous ovarian stimulation: BMI more than 30 .
Exclusion criteria: low responder patients; high responder patients; using donated oocyte and donated egg; single ovary; endometriosis; if patient's husband need to use TESE and PESA.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Tehran University of Medical Sciences, Keshavarz BLVD, Tehran
City
Tehran
Postal code
Approval date
2016-01-13, 1394/10/23
Ethics committee reference number
IR.TUMS.REC.1394.1647
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Number of oocyte metaphase 2
Timepoint
After ovarian puncture
Method of measurement
Microscope- by counting oocyte
Secondary outcomes
1
Description
Age
Timepoint
Chronological age
Method of measurement
Birth Certificate - year
2
Description
time of infertility
Timepoint
At first
Method of measurement
Interviews with patient - year
3
Description
Type of infertility
Timepoint
At first
Method of measurement
Interviews with patient - Infertility divided in two groups: primary (no pregnancy history) and secondary
4
Description
Chemical pregnancy
Timepoint
Two weeks after transfer
Method of measurement
Blood test - bhcg titration
5
Description
Clinical pregnancy
Timepoint
Four weeks after transfer
Method of measurement
Vaginal sonography - View gestational sac and fetal heart rate
6
Description
The number of matured follicle
Timepoint
Before puncture
Method of measurement
Vaginal sonography - The number of matured oocyte with size of18mm or more
7
Description
The number of antral follicle
Timepoint
At first
Method of measurement
Vaginal sonography - The number of antral follicle with size of 2-9 mm in follicular phase.
8
Description
The number of punctured oocyte
Timepoint
After puncture
Method of measurement
Microscope - The number of punctured oocyte.
9
Description
The number of fetus
Timepoint
After puncture
Method of measurement
Microscope-The number of fetuses after injection.
10
Description
The number of transferred fetus
Timepoint
In the time of transfer
Method of measurement
Microscope - The number of fetuses transfer in uterine.
11
Description
The days stimulation
Timepoint
At first of cycle
Method of measurement
Documents - The number of days that using gonadotropin
12
Description
Endometrial thickness
Timepoint
Before transfer
Method of measurement
Vaginal sonography - mm
13
Description
BMI
Timepoint
At first
Method of measurement
Examination of patient - Dividing weight in kg by the square of one's height in cm
14
Description
The number of drug used
Timepoint
In the end of treatment
Method of measurement
Documents - The number of drugs using for ovarian stimulation.
Intervention groups
1
Description
In Agonist -Antagonist protocol in second day of cycle agonist GNRH (DECAPEPTYL0.1MG)used SC for 3 days and then gonadotropin (Gonal-f ) administered. After 6 days vaginal sonography done frequently and when one 14 mm follicle appears in sonography , antagonist GNRH (cerotide) used SC until two 18mm follicles appeared .Then HCG in 5000 unit injected IM and after36 hours oocytes punctured.
Category
Treatment - Drugs
2
Description
In Long protocol in second or third day of cycle OCP started for 21 days. In Mid-luteal phase agonist GNRH (SUPERFACT) administered for 7 days and menstruation started and In second or third day of next cycle the dose of agonist decrease to half of previous dose. Then gonadotropin (Gonal-f ) administered. After 6 days vaginal sonography done frequently until two 18mm follicles appeared .Then HCG in 5000 unit injected IM and after36 hours oocytes punctured.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr Fateme Fakhar Moghadam
Street address
Shariati Hospital, Jalal-Al-Ahmad BLV intersection Northern Kargar, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Fateme Fakhar Moghadam
Street address
Shariati Hospital, Jalal Al Ahmad Intersection, Northern Kargar Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Shariati Hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr Fateme Fakhar Moghadam
Position
General Medicine and Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Jalal Al Ahmad Intersection, Northern Kargar Street, Tehran
City
Tehran
Postal code
Phone
+98 21 2207 4679
Fax
Email
haniyehfm@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Fateme Sarvi
Position
Fellowship of Infertility
Other areas of specialty/work
Street address
Jalal Al Ahmad Intersection, Northern Kargar Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8490 2000
Fax
Email
sarvi.fateme@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr Fateme Fakhar Moghadam
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)