Protocol summary
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Study aim
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Comparison of the effectiveness of GnRH agonist stop-Antagonist protocol versus GnRH antagonist protocol on fertility outcomes in poor respondent IVF candidate patients
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Design
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This study is designed as a randomized, phase 3 clinical trial with parallel groups, and a sample size of 74 participants. The randomization method will be the block randomization method.
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Settings and conduct
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The study will be conducted at Arash Women's Hospital on all women undergoing IVF. Patients who signed informed consent will be randomly divided into two groups. The first group will receive the Agonist stop Antagonist porotocol and the other group received the GnRH Antagonist protocol. The random allocation and final outcome of the study will be assessed by a person who is unaware of the study process. Also, the statistician will be unaware of the study process
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: The criteria for diagnosing poor ovarian response are two of the following:1- Age 40 or older 2 - History of poor ovarian response (POR) in the previous cycle (oocyte less than 3 in a conventional protocol), 3-Antral follicle count (AFC) less than 5-7 or Anti-Müllerian hormone (AMH) <0.5-1.1. In addition, twice poor ovarian response after maximal ovarian stimulation is sufficient reason to introduce the individual as POR without the need for other criteria.
Exclusion criteria: Polycystic ovarian syndrome, Hypothalamic amenorrhea, Repeated IVF failure
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Intervention groups
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In the IVF process, the first group will receive the Agonist stop Antagonist protocol
Group 2 will Receive the GnRH Antagonist protocol.
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Main outcome variables
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number of oocytes, M II oocytes, and embryos and embryo quality
General information
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Reason for update
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Due to the prevalence of Covid-19 and the reluctance of most patients to transfer fresh embryos in the cycle has begun, so we faced a reduction in sample size, so we requested a change in the protocol to investigate the effect of these treatments on oocyte count ,oocyte quality and embryo quality regardless of pregnancy and pregnancy outcomes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110731007165N10
Registration date:
2020-12-15, 1399/09/25
Registration timing:
registered_while_recruiting
Last update:
2021-07-04, 1400/04/13
Update count:
1
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Registration date
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2020-12-15, 1399/09/25
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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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Expected recruitment start date
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2020-12-10, 1399/09/20
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Expected recruitment end date
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2021-08-01, 1400/05/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effectiveness of GnRH agonist stop-Antagonist protocol versus GnRH antagonist protocol in poor respondent IVF candidate patients
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Public title
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Comparison of the effectiveness of GnRH agonist stop-Antagonist protocol versus GnRH antagonist protocol in IVF candidate patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The criteria for diagnosing poor ovarian response are two of the following:1- Age 40 or older 2 - History of poor ovarian response (POR) in the previous cycle (oocyte less than 3 in a conventional protocol), 3-Antral follicle count (AFC) less than 5-7 or Anti-Müllerian hormone (AMH) <0.5-1.1.
Twice poor ovarian response after maximal ovarian stimulation is sufficient reason to introduce the individual as POR without the need for other criteria.
Exclusion criteria:
Polycystic ovarian syndrome
Hypothalamic amenorrhea
Uterine congenital anomalies and uterine cavity abnormalities (Bicorn uterus, Unicorn uterus, Asherman, Liomyuma, Polyp, etc.)
Repeated IVF failure (more than three consecutive failures)
Endocrine disorders (diabetes, thyroid disease, antipolipid syndrome, cardiovascular and liver disease),
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Age
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From 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
74
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The randomization list will be prepared by a statistician using the block randomization method (using the site:www.sealedenvelope.com). Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained. Then the treatment will be performed based on the kind of treatment in the envelope.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind.
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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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2020-10-31, 1399/08/10
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1399.694
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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Female infertility
Primary outcomes
1
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Description
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Number of mature oocytes
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Timepoint
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During IVF process
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Method of measurement
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Embryologist opinion
2
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Description
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Number of mature oocytes at retrieval
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Timepoint
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During IVF process
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Method of measurement
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Embryologist opinion
Secondary outcomes
1
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Description
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Embryo quality
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Timepoint
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Embryo formation
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Method of measurement
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By the embryologist
2
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Description
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oocyte count
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Timepoint
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Puncture Day
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Method of measurement
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by embryologist
Intervention groups
1
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Description
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Intervention group: GnRH(0.1 mg/daily) will be injected from mid-luteal phase until mense then in the second day of menstrual cycle recombinant FSH with LH will be injected. When the size of the follicle reaches 13-14 mm, the GnRH antagonist will be injected until trigger day. When the size of the follicle will reach above 18 mm HCG will be injected and 36 hours later ovarian puncture will be performed.
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Category
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Treatment - Drugs
2
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Description
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Group2:Ovarian stimulation with GnRH will be started from 2 days of the menstrual cycle. When the size of the follicle will reach above 13-14 mm GnRH antagonist (0.2 mg/daily) will be injected until trigger day. When the size of the follicle will reach above 18 mm HCG will be injected and 36 hours later ovarian puncture will be performed. One to three embryos will be transferred on the third day and luteal phase support is performed with progesterone.
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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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Tehran 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available