Protocol summary
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Study aim
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Comparing the mean of Cetrotide injections, number of oocytes and embryos obtained with the A, B, C quality,gonadotropin dosage , duration of the ovarian stimulation period and frequency of OHSS (Ovarian Hyperstimulation Syndrome) in Flexible group with Fixed group.
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Design
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Phase 3 clinical trial with a control group will be conducted in parallel groups on 150 patients. Randomization of the samples will be done with a simple randomization method according to the generated list. The list of random numbers will be generated by a statistical consultant using Random Allocation1 software. 75 patients will be in the intervention group and 75 patients will be in the control group.
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Settings and conduct
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This clinical trial will be conducted in Yazd Infertility Research Center. The study and control cases will be selected among patients with Polycyctic ovary syndrome, referring to the infertility clinic ,candidates for Assisted reproductive technologies. People who meet the criteria for entering the study will be randomly placed in two groups of Fixed and Flexible.Blinding is not performed.
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Participants/Inclusion and exclusion criteria
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Women with polycystic ovary syndrome, candidate for ART(Assisted reproductive techniques) ,aged 20-40 with BMI in range of 20-30,without sever endometriosis and pelvic neoplasia and sever male factor infertility.
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Intervention groups
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Both groups will be selected from women with PCOS candidate for ART. On the 2th day of the menstrual cycle, ultrasound will be performed and gonadotropin rFSH will be injected daily and will be randomly divided into two groups.In Fixed group ,from the 5th day of gonadotropin administration while in Flexible group if there was a dominant follicle 12- 14 mm , Cetrotide will be administered daily and will be continue until the trigger day.
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Main outcome variables
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The number of M2 oocyte
General information
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Reason for update
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Update clinical trial based on the latest changes in the method and recruiment dates
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20091018002604N6
Registration date:
2023-10-09, 1402/07/17
Registration timing:
prospective
Last update:
2024-05-12, 1403/02/23
Update count:
1
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Registration date
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2023-10-09, 1402/07/17
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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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2023-10-12, 1402/07/20
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Expected recruitment end date
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2024-02-29, 1402/12/10
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Actual recruitment start date
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2023-10-12, 1402/07/20
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Actual recruitment end date
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2024-02-29, 1402/12/10
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Trial completion date
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empty
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Scientific title
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Evaluation and comparison of Fixed versus Flexible Gonadotropin Releasing Hormone Antagonist Protocol in Controlled Ovarian Stimulation for In vitro Fertilization in Women with Polycystic Ovary Syndrome- A randomized clinical trial
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Public title
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Evaluation of Fixed versus Flexible Gonadotropin Releasing Hormone Antagonist Protocol for In vitro Fertilization in Women with Polycystic Ovary Syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women with Polycystic Ovary Syndrome (PCOS) candidate for ART(Assisted Reproductive Techniques)
Age in range of 20-40 years
BMI in range of 20-30 kg/m2
Exclusion criteria:
Sever endometriosis
Sever male factor infertility
Pelvic neoplasia
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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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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:
150
Actual sample size reached:
150
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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, we will use the software 'Random Allocation1' (https://random-allocation-software.software.informer.com/1.0/), and based on the simple randomization method, a statistician will produce the list of samples for the two study groups. In this software, to generate a list of random numbers, we will first determine the number of study groups and the total number of samples (2 and 150, respectively). Then, from the list of sample randomization methods, we will choose the simple randomization method for parallel groups, ensuring an equal number of samples in both groups. Subsequently, a random list based on the groups and the number of samples in each group will be generated.The randomized unit will be the referring person, who will be randomly assigned to each group by the researcher after obtaining informed consent and according to the generated list. To maintain the concealment of randomization, we will use the sealed envelope method. These envelopes will be prepared in the same quantity as the samples and will contain the name of the intervention group.
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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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2023-08-06, 1402/05/15
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Ethics committee reference number
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IR.SSU.RSI.REC.1402.013
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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The number of M II oocytes
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Timepoint
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After ovarian puncture
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Method of measurement
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Microscopic manual counting by embryologist
Secondary outcomes
1
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Description
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The number of embryos with qualities of A,B,or C.
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Timepoint
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1-2 days after ovarian puncture
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Method of measurement
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Microscopic manual counting by embryologist
2
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Description
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The duration of controlled ovarian stimulation period
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Timepoint
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Immediatly after controlled ovarian stimulation
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Method of measurement
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Time scale(day)
3
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Description
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The dosage of Gonadotropin used
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Timepoint
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After controlled ovarian stimulation
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Method of measurement
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Counting
4
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Description
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The number of Cetrotide injections
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Timepoint
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After controlled ovarian stimulation
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Method of measurement
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Counting
5
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Description
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The incidence of OHSS(Ovarian Hyperstimulation Syndrome)
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Timepoint
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3_7 days after trigger
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Method of measurement
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Through phisycal examination and Ultra sonography
Intervention groups
1
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Description
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Intervention group 1: (Fixed group) on the second day of the menstrual cycle, ultrasound will be performed and 150 IU rFSH gonadotropin will be injected daily . Then, starting from the fifth day of gonadotropin administration, 0.25 mg of sterotide will be administered daily until the trigger day. In both groups, with ultrasound monitoring when there are at least 2 follicles ≥17 mm in size, triggering with HCG (1500-5000 IU) and GnRH agonist or GnRH agonist alone will be done. 34-36 hours after the trigger, ovarian puncture will be performed under general anesthesia and ultrasound guidance. 72 hours after ovarian puncture, one or two cleavage stage embryos will be transfered, the rest of the embryos will be frozen. If there is a risk of Ovarian Hyperstimulation syndrome(OHSS) or serum progesterone level ≥ 2.25 ng/ml, all embryos will be frozen. OHSS in the form of follicle count ≥ 25 or serum estradiol level ≥4000, is defined.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: (Flexible group) From the second day of the menstrual cycle, daily subcutaneous gonadotropin IU150 rFSH was started, then if there was a dominant follicle 12-14 mm, Cetrotide 0.25 mg was prescribed and it will continue until the trigger day. In both groups, with ultrasound monitoring, when there are at least 2 follicles ≥17 mm, triggering with HCG (1500-5000 IU) and GnRH agonist or GnRH agonist alone will be done . 34- 36 hours after the trigger, ovarian puncture will be performed under general anesthesia and ultrasound guidance. 72 hours after ovarian puncture, one or two cleavage stage embryos will be transfered and the rest of the embryos will be frozen. If there is a risk of Ovarian Hyperstimulation Syndrome (OHSS) or serum progesterone level ≥ 2.25 ng/ml, all Embryos will be frozen.OHSS is defined as follicle count ≥25 or serum estradiol level ≥4000.
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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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