Protocol summary
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Study aim
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the additional GnRH agonist administered at the time of implantation for luteal phase support in FET cycles improves the pregnancy outcome in frozen-thawed embryo transfer cycles (FET) cycles
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Design
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prospective parallel single blind controlled trial on 200 patients.for randomization was computerized with randomization table
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Settings and conduct
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Patients were administered estradiol valerate 6 milligrams daily and ASA 80 mg from day 2 of the cycle.vaginal sonography eas done on day ; since the endometrial thickness reached 8 mm,daily vaginal progesterone suppositories(total dose 800 mg daily) was administered . Randomization was done on the day of embryo transfer by a computer-generated table.Blindness was done for researchers.Patients were divided to group 1(n=100) to whom a single dose of GnRH agonist( 0.1 mg triptorelin) was administered three days after transfer and group 2 (n=100) ,who did not receive agonist.Both groups received daily vaginal progesterone suppositories(800 mg daily) plus estradiol valerate( 6 mg dai-ly)
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:patients in frozen-thawed embryo transfer cycle who have freezed embryo due to previous OHSS or supernumerary freezed embryos
age of 18 to 40years;exclusion:patients below the age of 18 and over 40 years;oocyte recipients; patients who had systemic or endocrine disorders ; submucous fibroids or intrauterine adhesions with or without history of previous surgery
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Intervention groups
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patients in frozen-thawed embryo transfer cycle
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Main outcome variables
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primary outcome measure was clinical pregnancy rate.secondary outcome measures were implantation rate,chemical ,ongoing pregnancy rate and abortion rate .
General information
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Reason for update
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defect in previous data
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015031021420N1
Registration date:
2015-04-12, 1394/01/23
Registration timing:
retrospective
Last update:
2021-03-08, 1399/12/18
Update count:
1
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Registration date
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2015-04-12, 1394/01/23
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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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Vice Chancellor for research of Yazd University of Medical Sciences
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Expected recruitment start date
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2014-04-03, 1393/01/14
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Expected recruitment end date
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2015-01-20, 1393/10/30
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Actual recruitment start date
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2014-04-03, 1393/01/14
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Actual recruitment end date
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2015-01-01, 1393/10/11
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Trial completion date
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2015-01-01, 1393/10/11
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Scientific title
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Effect of single dose of GnRH-agonist on pregnancy outcome in frozen-thawed embryo transfer cycles
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Public title
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GnRH agonist administration in assisted reproductive program
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
patients in frozen-thawed embryo transfer cycle who have freezed embryo due to previous OHSS or supernumerary freezed embryos
age of 18 to 40years
Exclusion criteria:
patients below the age of 18 and over 40 years, , , endometriosis,
oocyte recipients
patients who had systemic or endocrine disorders such as diabetes mellitus and thyroid disorders
submucous fibroids or intrauterine adhesions
with or without history of previous surgery
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
221
Actual sample size reached:
200
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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simple, randomization table
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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participants, data evaluators
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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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A computer-generated randomization table was created for
the study population .Allocation concealment was ensured by the use of sealed envelopes on the day of embryo transfer
Ethics committees
1
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Ethics committee
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Approval date
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2014-06-22, 1393/04/01
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Ethics committee reference number
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314
Health conditions studied
1
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Description of health condition studied
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Female 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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28 days after transfer
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Method of measurement
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vaginal sonography
Secondary outcomes
1
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Description
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chemical pregnancy
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Timepoint
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14 days after transfer
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Method of measurement
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BHCG test
Intervention groups
1
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Description
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intervention group:a single dose of GnRH agonist( 0.1 mg triptorelin) was administered three days after transfer
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Category
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Treatment - Drugs
2
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Description
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Control group do not receive triptoreline0.1mg.
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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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Yazd Research and Clinical center for infertility
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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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only some data like main outcomes can be shared.
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When the data will become available and for how long
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from 1395
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To whom data/document is available
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academic and scientific researchers
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Under which criteria data/document could be used
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no specific circumstances
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From where data/document is obtainable
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m_fmojtahedi@yahoo.com
maryam farid Mojtahedi
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What processes are involved for a request to access data/document
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by e-mail
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Comments
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