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General information
110
152
110152
2017-09-21, 1396/06/30
2017-08-01, 1396/05/10
2017-0908-2101 00:00:00
2017-11-30, 1396/09/09
2017-10-07, 1396/07/15
2017-1110-3007 00:00:00
2018-01-30, 1396/11/10
2017-11-30, 1396/09/09
20182017-0111-30 00:00:00
Infertile women who candidate for IVF cycles underwent GnRH antagonist protocol
Infertile women who candidate for IVF cycles underwent GnRH antagonist protocol
Fresh embryo transfer cycles
Infertile women who candidate for IVF cycles underwent GnRH antagonist protocol Fresh embryo transfer cycles
زنان نابارور کاندید ورود به سیکلهای IVF (In vitro fertilization) تحت پروتکل آنتاگونیست
زنان نابارور کاندید ورود به سیکلهای IVF (In vitro fertilization) تحت پروتکل آنتاگونیست
سیکلهای با انتقال جنین تازه
زنان نابارور کاندید ورود به سیکلهای IVF (In vitro fertilization) تحت پروتکل آنتاگونیست سیکلهای با انتقال جنین تازه
Protocol summary
Study aim
The aim of this randomized clinical trial is comparison of the effect of FSH (follice - stimulating hormone) administration plus HCG(human chorionic gonadotropin) at the time of oocyte trigger and HCG alone on IVF cycles outcomes as well as ovarian hyperstimulatiopn syndrom.
Design
A total of 109 women who met inclusion criteria, who were convinced about the research design and signed a written consent form were divided into two groups during a not-blinded, phase 2, parallel groups, without control group randomized clinical trial.
Settings and conduct
Regarding the importance of oocyte triggering in IVF cycles, 109 women at Yazd Research and Clinical Center who were candidate for IVF, were randomly divided into two groups for oocyte triggering (one group using FSH plus hCG or hCG alone in another group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women undergoing IVF and GnRH antagonist protocol.
Non inclusion criteria: severe male factor infertility, cycle cancellation due to changing to intrauterine insemination and freeze-all policy, a cycle containing preimplantation genetic diagnosis (PGD) and estradiol level of more than 2500 pg/mL, donor or surrogate cycle.
Intervention groups
Intervention group 1: Oocyte triggering using FSH plus hCG; Intervention group 2: Oocyte triggering using hCG alone
Updating the clinical trial according to the last changes in case number and results
Acronym
IRCT registration information
IRCT registration number:IRCT2017082724512N5
Registration date:2017-09-22, 1396/06/31
Registration timing:registered_while_recruiting
Last update:2021-03-23, 1400/01/03
Update count:2
Registration date
2017-09-22, 1396/06/31
Registrant information
Name
Abbas Aflatoonian
Name of organization / entity
Yazd research and clinical center for infertility
Country
Iran (Islamic Republic of)
Phone
+98 358247085
Email address
abbas-aflatoonian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Reproductive Sciences Institute ,Shahid Sadoughi University of Medical Sciences.
Expected recruitment start date
2017-08-01, 1396/05/10
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
2017-08-01, 1396/05/10
Actual recruitment end date
2017-10-07, 1396/07/15
Trial completion date
2017-11-30, 1396/09/09
Scientific title
Comparison between FSH administration with HCG and HCG alone at the time of trigger in IVF cycles outcomes
Public title
The effect of FSH administration with HCG at the time of trigger on IVF cycles outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women who candidate for IVF cycles underwent GnRH antagonist protocol
Fresh embryo transfer cycles
Exclusion criteria:
Women with history of endocrine disorders
serum estradiol>2500pg/ml in day of trigger
Intrauterine abnormality (uterine polyp; uterine myoma)
Severe male factor
Cycle cancellation or changing to intrauterine insemination
A cycle containing preimplantation genetic diagnosis (PGD)
Women who did not undergo embryo transfer due to the freeze-all policy
Donor or surrogate cycle
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
152
Actual sample size reached:
109
Randomization (investigator's opinion)
Randomized
Randomization description
A number of 109 women who met inclusion criteria were explained about the procedure and after signing the written consent form, divided randomly into two groups using random numbers table.
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
Ethics Committee of Yazd Reproductive Sciences Institute Shahid Sadoughi University