The aim of study is to compare the efficacy of two different formulations of GnRH agonist, short-acting and long-acting, for ART protocols. 100 women who are candidate for ART cycles are randomly divided into two groups . In group I, the patients receive one single injection of 1.87 mg Triptoreline in previous mid-luteal phase. In group II patients receive Decapeptyle 0.1 mg per day from previous mid-luteal phase.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108116420N9
Registration date:2011-08-27, 1390/06/05
Registration timing:retrospective
Last update:
Update count:2
Registration date
2011-08-27, 1390/06/05
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd reaserch and clinical center for infertility
Expected recruitment start date
2008-03-01, 1386/12/11
Expected recruitment end date
2009-08-01, 1388/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pregnancy outcome in half-dose Triptorelin and short-acting Decapeptyl in long protocol in assisted reproductive thechnology cycles
Public title
Comparison of two protocols for ovarian stimulation in assisted reproductive technology
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : female aged between 18-38 years; history of infertility at least for 1 year and FSH concentration in day 3 of menstrual cycle <12mIU/ml. Exlusion criteria: history of pelvic surgery; abnormal thyroid function or other endocrinopathies; and severe male factor (azospermia)
Age
From 18 years old to 38 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Yazd reserch and clinical center for infertility
Street address
Bouali avenue
City
Yazd
Postal code
Approval date
2009-07-12, 1388/04/21
Ethics committee reference number
781
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
chemical pregnancy
Timepoint
2 weeks
Method of measurement
serum BHCG
Secondary outcomes
1
Description
No of gonadotropin ampuls
Timepoint
2 weeks
Method of measurement
count
Intervention groups
1
Description
Intervention: In long-acting GnRH-a group (group I), half-dose ( 1.87 mg ) of Triptuneline (Diphereline® S.R. 3.75mg) is administrated in a single intramuscular injection in mid-luteal phase (day 21) of the previous menstrual cycle. Ovarian stimulation is done from day 2 of menstrual cycle with daily administration (100-150 IU) of human recombinant follicle-stimulating Hormone and continue until the day of hCG injection. Ovarian response is monitored using serial ultrasound examination. When the leading follicle is larger than 18mm in diameter or at least two follicles are larger than 16mm, 10/000 IU hCG (human chorionic gonadotropin) is injected intramuscularly. Oocytes are retrieved 36 hours after hCG injection using a 17-gauge aspiration needle under transvaginal ultrasound guidance.
Category
Treatment - Drugs
2
Description
Control: In short acting group (group II), Decapeptyl is started 0.1 mg per day subcutaneously from previous mid-luteal phase and continue until the day of hCG injection. Ovarian stimulation is done from day 2 of menstrual cycle with daily administration (100-150 IU) of human recombinant follicle-stimulating hormone and continue until the day of hCG injection. Ovarian response is monitored using serial ultrasound examination. When the leading follicle is larger than 18mm in diameter or at least two follicles are larger than 16mm, 10/000 IU hCG is injected intramuscularly. Oocytes are retrieved 36 hours after hCG injection using a 17-gauge aspiration needle under transvaginal ultrasound guidance.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd reaserch and clinical center for infertility
Full name of responsible person
Martam Eftekhar
Street address
Safayeh, Boali Ave
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd reaserch and clinical center for infertility
Full name of responsible person
Dr Abbas Aflatounian
Street address
Bouali Ave, Safayeh
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd reaserch 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
Reaserch and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Assisted professor
Other areas of specialty/work
Street address
Bouali Ave, Safayeh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd reaserch and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Assisted professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Bouali Ave, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Assisted professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Bouali Ave, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
eftekhar@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)