Protocol summary
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Study aim
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Compare the reproductive outcomes of fresh vs frozen embryo transfer in high responder IVF patients triggered with GnRHa
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Design
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Women at risk for OHSS who were stimulated with GnRH antagonist protocol and triggered with GnRHa for oocyte triggering were randomly divided into two groups of either fresh embryo transfer or frozen embryo transfer on the day of oocyte triggering. In this not-blinded, phase 2 clinical trial without control group, randomization was performed using random number table.
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Settings and conduct
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In this multicenter, randomized clinical trial, infertile women at risk of OHSS were recruited at three fertility clinics in Iran; Yazd Research and Clinical Center for Infertility, Yazd Madar Hospital, Mashhad Novin Fertility and Infertility Center. Women were randomized into two groups. Pregnancy outcome were assessed in FET and fresh embryo transfer groups.
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Participants/Inclusion and exclusion criteria
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Patients with OHSS risk at the age between 20-40 yr and having a number of 14-25 follicles ≥12 mm on the day of trigger and a body mass index >18 and <35 kg/m2 without a previous history of OHSS development.
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Intervention groups
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Group 1: Women were stimulated with GnRH antagonist protocol and triggered with GnRHa for oocyte triggering with fresh embryo transfer
Group 2: Women were stimulated with GnRH antagonist protocol and triggered with GnRHa for oocyte triggering with frozen embryo transfer
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Main outcome variables
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The primary outcome parameter was clinical pregnancy and the secondary outcome parameters were chemical pregnancy; live birth; OHSS development; and perinatal outcomes.
General information
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Reason for update
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Updating the trial regarding actual sample size, actual recruitment start and end dates
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016092224512N4
Registration date:
2016-10-03, 1395/07/12
Registration timing:
retrospective
Last update:
2021-03-24, 1400/01/04
Update count:
1
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Registration date
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2016-10-03, 1395/07/12
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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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Research Deputy, Shahid Sadoughi Univesity of Medical Science
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Expected recruitment start date
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2014-01-01, 1392/10/11
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Expected recruitment end date
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2015-12-30, 1394/10/09
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Actual recruitment start date
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2014-01-01, 1392/10/11
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Actual recruitment end date
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2015-12-30, 1394/10/09
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Trial completion date
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2017-01-30, 1395/11/11
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Scientific title
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Comparison of Fresh and Frozen Embryo Transfer in GnRH Agonist Triggered patients: A Multicenter Study
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Public title
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Pregnancy outcome in Fresh versus Freeze embryo transfer
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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 20-40
Hyper responded patients
Detection of 14-25 follicles ≥ 12 mm on day of trigger
BMI >18 and <35 kg/m2
Exclusion criteria:
Patients with <14 follicles and > 25 ≥ 12 mm on day of trigge
Previous OHSS
Endocrine disorders
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Age
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From 20 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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No information
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Sample size
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Target sample size:
1280
Actual sample size reached:
280
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this multicenter, randomized clinical trial, 280 infertile women at risk of OHSS were enrolled in the study. All patients were informed about the research design and signed a written consent form. All women were randomly divided into two groups. Randomization was simple, individual using a 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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2013-12-09, 1392/09/18
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Ethics committee reference number
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IRCT2016092224512N4
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
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ICD-10 code description
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inability to achieve a pregnancy sterility, female NOS
Primary outcomes
1
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Description
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Clinical pregnancy 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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Fetal heart rate in ultra sonography
Secondary outcomes
1
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Description
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Chemical pregnancy rate
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Timepoint
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14 days after embryo transfer
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Method of measurement
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Beta-hCG using lab kit
2
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Description
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livebirth
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Timepoint
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36 weeks after embryo transfer
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Method of measurement
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A live-born baby
3
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Description
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Ovarian hyperstimulation syndrome
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Timepoint
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During ovarian stimulation
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Method of measurement
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Measurement of serum anti mullerian hormone level and antral follicle count
4
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Description
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Perinatal outcome
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Timepoint
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After live birth
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Method of measurement
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weight measurement, prematurity status
Intervention groups
1
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Description
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Intervention group 1: Freeze of all embryos according to embryo freezing standard protocol at the same cycle. Thaw all the embryos according to embryo thawing standard protocol and embryo transfer at the next cycle
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Category
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Treatment - Other
2
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Description
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Intervention group 2: Transfer of 2 fresh embryos at the same cycle Luteal phase support using oral Estradiol Valerat at the dose of 4 mg per day and progesterone (Cyclogest 400 mg) twice daily until observation of fetal heart activity
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Category
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Other
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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Research Deputy, Shahid Sadoughi University of 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
abbas_aflatoonian@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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