Protocol summary
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Study aim
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comparison of GnRH antagonist versus long GnRH agonist protocol in poor responders undergoing IVF
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Design
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The phase 3 clinical trial, with a control group, will be conducted in parallel on 170 patients. The randomization of the samples will be done with Weber's simple randomization method according to the generated list of random numbers. The list of random numbers will be generated using the Random Allocation 1 software by A statistical consultant will be produced.
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Settings and conduct
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This study is conducted by the clinical trial method in Yazd Research Institute of Reproductive Sciences. The studied and control cases will be selected from among the people with poor ovarian response referring to the infertility clinic who are candidates for assisted reproductive methods. People who meet the inclusion criteria will be randomly assigned to two Gnrh agonist and Gnrh antagonist groups in the cycle of controlled ovarian stimulation.
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Participants/Inclusion and exclusion criteria
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Women aged 18 to 42 with poor ovarian response are candidates for ART without severe endometriosis and severe male factor infertility.
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Intervention groups
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Both groups of weakly responding patients who are candidates for ART will be selected. On the second day of the menstrual cycle, ultrasound will be performed and rFSH gonadotropin will be injected daily. In the agonist group, they will receive a depot dose of GnRH intramuscularly from the 21st day of the cycle before ovarian stimulation. . In the antagonist group, if there is a dominant follicle of 14 mm, steroid will be prescribed daily and will continue until the day of the trigger.
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Main outcome variables
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, the number of oocytes obtained, the number of embryos obtained with the qualities of A, B, C, the dose of gonadotropin used, the length of the ovarian stimulation periodو clinical pregnancy
General information
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Reason for update
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Termination of the test and completion of information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110509006420N28
Registration date:
2024-01-30, 1402/11/10
Registration timing:
prospective
Last update:
2024-12-19, 1403/09/29
Update count:
2
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Registration date
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2024-01-30, 1402/11/10
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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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2024-01-30, 1402/11/10
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Expected recruitment end date
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2024-08-22, 1403/06/01
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Actual recruitment start date
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2024-01-31, 1402/11/11
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Actual recruitment end date
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2024-07-22, 1403/05/01
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Trial completion date
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2024-10-31, 1403/08/10
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Scientific title
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Evaluation and comparison of GnRH antagonist versus long GnRH agonist protocol in poor responders undergoing IVF from POSEIDON group3- 4: A randomized clinical trial
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Public title
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Evaluation of GnRH long-acting agonist protocols and GnRH antagonist protocol in controlled ovarian stimulation in in vitro fertilization in infertile women with poor ovarian response
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
IVF/ICSI candidates
Women who respond poorly to ovulation stimulation: ovarian reserve less than 1.2 ng/ml and AFC number less than 5 POSEIDON group 3-4
Women between the ages of 18 and 42
Exclusion criteria:
sever Asherman's history
Severe uterine adenomyosis
Egg donation cycles
Cases of severe male infertility (azoospermia)
Cases where surrogacy is used
Endocrine or metabolic diseases (hypothyroidism, hyperthyroidism)
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Age
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From 18 years old to 42 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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No information
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Sample size
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Target sample size:
170
Actual sample size reached:
170
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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 study, using the simple randomization method using the Random Allocation1 software (http://random-allocation software.informer.com\1) and based on the simple randomization method, the list of samples in the two groups studied by the expert Statistics will be generated. In this software, in order to generate a list of random numbers, first specify the number of groups to be studied as 2 and the total number of samples required as 170 people, and then from the list of sample randomization methods, the method (simple randomization method in parallel group) by considering the same number of samples in the groups. Then a random list will be generated based on the groups and the number of samples in each group. Randomly and after obtaining informed consent by the researcher, they are assigned to two groups. The sealed envelope method is used for concealment. The envelopes are prepared as many samples as each envelope contains the name of the intervention group for each sample. Is.
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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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2024-01-10, 1402/10/20
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Ethics committee reference number
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IR.SSU.RSI.REC.1402.019
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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Clinical pregnancy
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Timepoint
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4 weeks after embryo transfer
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Method of measurement
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sonography
Secondary outcomes
1
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Description
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rate of early abortion
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Timepoint
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the loss of the gestational sac or fetal heartbeat in clinically pregnant individuals prior to 8 weeks of gestational age
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Method of measurement
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sonography
2
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Description
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نرخ حاملگی مداوم
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Timepoint
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the continuation of pregnancy after 12 wk of gestational age.
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Method of measurement
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sonography
3
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Description
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Chemical pregnancy
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Timepoint
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2 weeks after embryo transfer
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Method of measurement
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pregnancy test
4
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Description
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Implantation
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Timepoint
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After a positive pregnancy test
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Method of measurement
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sonography
Intervention groups
1
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Description
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The GnRH antagonist group will start from the second day of the menstrual cycle, the ultrasound of gonadotropin IU225-300 rFSH signal-F daily subcutaneous injection. Then, if there is a dominant follicle ≥ 14 mm, the GNRH antagonist (Cetrotide 0.25 mg) is prescribed and will continue until the ovulation trigger day. With ultrasound monitoring, when there are The average follicle is ≥17 mm or one follicle is 18 mm, 10,000 hCG units were injected to induce the final maturation of follicles on the same day. Endometrial thickness and serum E2 level were measured for all 34-36 hours after the trigger under general anesthesia and ovarian puncture will be performed by ultrasound. became. 72 hours after ovarian puncture, two three-day-old embryos will be transferred and the remaining embryos will be frozen. If there is serum progesterone level ≥ 1.5ng/ml, all embryos will be frozen.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: In the GnRH agonist long protocol group, they received a zoladex 3.6 mg dose of GnRH depot analog sc from day 21 of the cycle before ovarian stimulation. From the second day of the menstrual cycle, the ultrasound of gonadotropin IU225-300 rFSH signal-F will be injected daily subcutaneously. The dose of the drug will be adjusted according to the response of the ovary and will continue until the ovulation trigger day. With ultrasound monitoring, whenThe average follicle is ≥17 mm or one follicle is 18 mm In order to induce the final maturation of the follicle, 10,000 units of HCG were injected on the same day. Endometrial thickness and E2 serum level were measured for all 34-36 hours after the trigger under general anesthesia and ovarian puncture will be performed under ultrasound guidance. 72 hours after ovarian puncture, two three-day-old embryos will be transferred and the remaining embryos will be frozen. If there is serum progesterone level ≥ 1.5ng/ml, all embryos will be frozen.
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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 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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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
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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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In order to receive data or other study documents, researchers working in academic and scientific institutions are allowed to apply
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Under which criteria data/document could be used
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To evaluate the accuracy of the data and use data to complete other researches
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From where data/document is obtainable
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Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran
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What processes are involved for a request to access data/document
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Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.
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Comments
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