Protocol summary
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Study aim
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To compare the efficacy of two different formulations of GnRH agonist; short-acting and long-acting, for ART protocols
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Design
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100 infertile women in a randomized clinical trial without control group, parallel, not-blinded, phase 2, were randomly divided into two groups using random number table.
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Settings and conduct
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In order to improve ART outcome, 100 infertile women who referred to Yazd Research and Clinical Center for Infertility were randomly divided into two groups of long-acting and short-acting GnRH ovarian stimulation protocol.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria : being female at the age of 18-38 years; history of infertility at least for 1 year; FSH concentration in day 3 of menstrual cycle <12 mIU/ml.
Non inclusion criteria: history of pelvic surgery; abnormal thyroid function or other endocrinopathies; severe male infertility (azoospermia)
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Intervention groups
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Intervention group 1: In long-acting GnRH agonist group , half-dose (1.87 mg) of Triptorelin was administrated in a single intramuscular injection on day 21 of the previous menstrual cycle.
Intervention group 2: In short acting group , Decapeptyl was started 0.1 mg per day subcutaneously from previous mid-luteal phase and continued until the day of HCG injection.
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Main outcome variables
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Implantation rate; clinical pregnancy rate
General information
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Reason for update
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Updating the trial according to the last changes in methods and adding results
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201108116420N9
Registration date:
2011-08-27, 1390/06/05
Registration timing:
registered_while_recruiting
Last update:
2021-03-16, 1399/12/26
Update count:
2
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Registration date
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2011-08-27, 1390/06/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Yazd reaserch and clinical center for infertility
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Expected recruitment start date
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2010-01-01, 1388/10/11
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Expected recruitment end date
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2011-12-30, 1390/10/09
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Actual recruitment start date
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2010-01-01, 1388/10/11
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Actual recruitment end date
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2011-12-30, 1390/10/09
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Trial completion date
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2012-02-15, 1390/11/26
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Scientific title
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Comparison of pregnancy outcome in half-dose Triptorelin and short-acting Decapeptyl in long protocol in assisted reproductive thechnology cycles
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Public title
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Comparison of two protocols for ovarian stimulation in assisted reproductive technology
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 18-38 years
History of infertility at least for 1 year
FSH concentration in day 3 of menstrual cycle <12 mIU/ml.
Exclusion criteria:
History of pelvic surgery
Abnormal thyroid function
Endocrinopathies
Severe male factor
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Age
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From 18 years old to 38 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
Actual sample size reached:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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100 infertile women who were informed about the research design and signed a written consent form, were randomly divided into two group using random number table.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2009-07-12, 1388/04/21
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Ethics committee reference number
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781
Health conditions studied
1
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Description of health condition studied
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infertility
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ICD-10 code
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N97.9
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ICD-10 code description
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Female infertility, unspecified
Primary outcomes
1
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Description
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Clinical pregnancy
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Timepoint
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7 weeks after embryo transfer
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Method of measurement
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Detecting fetal heart rate in sonography
2
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Description
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Implantation rate
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Timepoint
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7 weeks after embryo transfer
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Method of measurement
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The number of gestational sac divided by the number of transferred embryos
Secondary outcomes
1
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Description
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No of used gonadotropin ampuls
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Timepoint
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2 weeks
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Method of measurement
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count
Intervention groups
1
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Description
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Intervention group 1: 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.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: 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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Deputy of Research and Technology, Yazd Shahid Sadoughi Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All participant data sets are to be shared
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When the data will become available and for how long
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2 months after the result publication
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To whom data/document is available
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A journal in which the results are published
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Under which criteria data/document could be used
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Submission of an official application via the agent that is legally in charge
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From where data/document is obtainable
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Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran.
983538247085
eftekharmaryam@yahoo.com
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What processes are involved for a request to access data/document
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2 months after application
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Comments
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