Protocol summary
-
Study aim
-
comparison of ovulation triggering outcome using these two methods: standard dose of human chorionic gonadotropin and human chorionic gonadotropin In combination with gonadotropin releasing hormone in IVF/ICSI cycles
-
Design
-
This will be a two arm parallel group design of 100 patients candidate of IVF/ICSI , single blind randomised trial, with a computer-generated randomization list with a block size of 4, with 1:1 allocation.
-
Settings and conduct
-
Infertile women candidates of IVF/ICSI for different reason, having the study criteria who come to infertility clinic of Alzahra hospital will be entered into the study. ّFirst we will take an informed written consent and all part of the study will be explained to the patient. The treatment allocation will be placed in a sealed opaque envelope and picked up consecutively.
-
Participants/Inclusion and exclusion criteria
-
women who are candidate of IVF/ICSI and have some risk of ovarian hyperstimulation syndrome (OHSS) will be entered in the study. Every body who has diminished ovarian reserve [antral folicular count (AFC) less than 4 or anti-mulerian hormone (AMH) less than 1] will be excluded.
-
Intervention groups
-
during ovarian stimulation and ultrasound control when there is at least 5 or more follicles above 17 mm in diameter we administer 0.2 mg decapeptide and 2500 unit HcG for triggering ovulation in the study group or 2 ampoules of 5000 unit HcG equivalent to 10,000 units HcG in the control group.
-
Main outcome variables
-
number and quality of oocytes؛ number and quality of embryos؛ fertilization rate؛ imlantation rate؛ the rate of OHSS
General information
-
Reason for update
-
increment of the sample size and change in the dose of the drug in the control and intervention group because of the mistake in typing
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20101227005485N7
Registration date:
2019-07-18, 1398/04/27
Registration timing:
registered_while_recruiting
Last update:
2022-02-22, 1400/12/03
Update count:
1
-
Registration date
-
2019-07-18, 1398/04/27
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-06-22, 1398/04/01
-
Expected recruitment end date
-
2019-12-22, 1398/10/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
comparison of ovulation triggering outcome using these two methods: standard dose of human chorionic gonadotropin and human chorionic gonadotropin In combination with gonadotropin releasing hormone in IVF/ICSI cycles
-
Public title
-
comparison of standard dose of human chorionic gonadotropin and human chorionic gonadotropin In combination with gonadotropin releasing hormone in IVF/ICSI cycles
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
women who are candidate of IVF/ICSI and have some risk of OHSS will be entered in the study.
Exclusion criteria:
every body who have diminished ovarian reserve. (AFC<4 or AMH<1)
-
Age
-
From 20 years old to 40 years old
-
Gender
-
Female
-
Phase
-
4
-
Groups that have been masked
-
- Participant
- Care provider
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
100
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
A computer-generated randomization list with a block size of 4, with 1:1 allocation will be used to randomize patients. In such a case, one control will be checked for each intervention and with each of the 4 patients enrolled in the study, the two groups are balanced in terms of control and intervention.
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
The treatment allocation will be placed in a sealed, opaque, envelope and picked up consecutively. in the manner that the participant, the outcome evaluator and the analyzer will not be aware of the type of the drug.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-05-07, 1398/02/17
-
Ethics committee reference number
-
IR.TBZMED.REC.1398.129
Health conditions studied
1
-
Description of health condition studied
-
infertility
-
ICD-10 code
-
N97
-
ICD-10 code description
-
Female infertility
Primary outcomes
1
-
Description
-
number and quality of resulted oocytes
-
Timepoint
-
the day of oocytes pick up
-
Method of measurement
-
microscopic evaluation
2
-
Description
-
fertilization rate
-
Timepoint
-
24 hours after intra-cytoplasmic sperm injection
-
Method of measurement
-
microscope
3
-
Description
-
implantation rate
-
Timepoint
-
2 weeks after embryo transfer
-
Method of measurement
-
Measurement of beta-hCG
4
-
Description
-
number and quality of embryos
-
Timepoint
-
after 24 hours, day 3 and day 5
-
Method of measurement
-
microscopic evaluation
Secondary outcomes
1
-
Description
-
ovarian hyperstimulation syndrome
-
Timepoint
-
the day of oocyte pick-up and a week later
-
Method of measurement
-
history, physical examination and laboratory tests
Intervention groups
1
-
Description
-
Intervention group: 2500 unit human chorionic gonadotropin In combination with 0.2 miligram gonadotropin releasing hormone
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: 10000 unit human chorionic gonadotropin for triggering
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Tabriz University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available
-
Title and more details about the data/document
-
only a part of data could be shared
-
When the data will become available and for how long
-
2 years after publishing the results, the data could be attained.
-
To whom data/document is available
-
data will be given for every academic person who is interested in this field.
-
Under which criteria data/document could be used
-
for utilization in researches like in metha-analyses
-
From where data/document is obtainable
-
the applicants can mail there request to the person responsible for scientific inquiries.
-
What processes are involved for a request to access data/document
-
after application, data will be sent in two weeks.
-
Comments
-