Protocol summary
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Study aim
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Determining the effect of oral L-arginine consumption on uterine artery resistance in women with recurrent implant failure
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Design
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The present study is a randomized clinical trial using a block randomization and double-blind method. Blocks of 4 random number tables are used to allocate individuals to two control and study groups. The sample size was calculated based on similar studies and statistical formulas and was 72 people in total and 36 people in each group.
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Settings and conduct
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Research environment : the infertility clinic of Fatemeh Hospital, Hamadan, the research period: 2022-2023. The research population : all infertile women who are candidates for IVF with a history of 2 implantation failures . The research sample: infertile woman who is a candidate for IVF with a history of 2 implantation failures with good quality embryo transfer and a suitable endometrium with the inclusion criteria for the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Infertile women aged 18-41 years, candidates for IVF with a history of 2 failures, with a suitable endometrium and good quality embryos, and without chronic diseases, non-smokers, endometriosis, without hormonal disorders, immune disorders, thrombophilia, antiphospholipid antibodies, mutations in factor V, prothrombin, chromosomal disorders. Exclusion criteria: patients with side effects of L-arginine, cancellation of the treatment cycle for any reason, unwillingness to continue participating in the study.
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Intervention groups
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In the intervention group of women with recurrent implant failure and receiving drugs (including: folic acid, vitamin D3, B complex and probiotic) and standard protocol (LONG with suppression) take oral L-arginine supplement from the luteal phase at a rate of 3 g Receive daily for 20 days.
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Main outcome variables
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Uterine artery resistance in women IVF candidates with RIF,Successful embryo transfer
General information
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Reason for update
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The study needs to be updated due to the addition of a series of inclusion and exclusion criteria.
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Acronym
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RIF(Frequent implantation (failure
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IRCT registration information
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IRCT registration number:
IRCT20220317054318N1
Registration date:
2022-05-01, 1401/02/11
Registration timing:
prospective
Last update:
2025-01-08, 1403/10/19
Update count:
1
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Registration date
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2022-05-01, 1401/02/11
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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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2022-05-22, 1401/03/01
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Expected recruitment end date
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2023-02-20, 1401/12/01
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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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The effect of oral L-arginine consumption on uterine artery resistance in women with recurrent implant failure
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Public title
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The effect of oral L-arginine consumption on uterine artery resistance in women with recurrent implant failure
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Infertile women aged 18-41 years
Infertile IVF candidate women with a history of failure twice
Women with endometrium suitable for embryo transfer
Women with good quality embryos for transfer
Women who have passed 2 months or more since the last ICSI test and transfer.
Women who have the opportunity to attend the follow-up according to the plan and have informed consent
Women with a normal size and shape of the uterus that has been confirmed by ultrasound or hysteroscopy
Exclusion criteria:
Patients who use nitrite or organic nitrate at the same time
Women with chronic diseases such as: severe liver, kidney, or cardiovascular failure, patients with a history of stroke or myocardial infarction
Women smokers
Women with stage 3 and 4 endometriosis
Women with a known etiology of implant failure such as anatomical disorders (diagnosed by hysterosalpingography), hormonal disorders, immunological disorders, trophoblasts, antiphospholipid antibodies, mutation in factor V, pro-thrombin, crew disorders Musomes are excluded from the study
Patients with side effects of L-arginine
Canceling the treatment cycle for any reason
Unwillingness of the person to continue participating in the study
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Age
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From 18 years old to 41 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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- Participant
- Outcome assessor
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Sample size
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Target sample size:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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For this purpose, a random block is used. 18 sheets of paper are prepared and the letter A is written on 9 sheets and the letter B is written on the other 9 sheets. The sheets are mixed together and placed in a box and placed in a drawer. And with the reference of each person eligible to enter the study, one of the sheets is randomly taken out and based on whether it is group A or B, it is given to the intervention and control group and the sheets are taken out until every 18 sheets. If it is not pulled out, it will not be returned to the drawer, and after randomly pulling out all 18 sheets, all the sheets will be returned to the drawer and the above operation will be continued up to 4 times on the next 18 patients, ie completing the sample volume to 72.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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L-arginine and placebo are exactly the same, and a technician who is not in the research plan prepares the drugs and gives them to the doctor, and the codes remain secret until the end of the research, so the patient and the doctor measure the outcome. And the statistical consultant will not know which group these results belong to until the end of the study and after the disclosure of the codes.
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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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2022-04-09, 1401/01/20
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Ethics committee reference number
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IR.UMSHA.REC.1401.037
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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N97.9
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ICD-10 code description
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Female infertility, unspecified
Primary outcomes
1
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Description
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Uterine vascular resistance
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Timepoint
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At the beginning of the intervention and after taking L-arginine
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Method of measurement
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Color Doppler ultrasound
Secondary outcomes
1
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Description
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Pregnancy
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Timepoint
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After taking the drug and transferring the fetus
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Method of measurement
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B-HCG titration test
Intervention groups
1
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Description
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Intervention group: In the intervention group, women with recurrent implant failure, in addition to receiving drugs (including: folic acid, vitamin D3, B complex and probiotics) and standard protocol (LONG with suppression), take Karen brand oral L-arginine supplement from the luteal phase to They receive 3 grams daily for 20 days.
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Category
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Treatment - Drugs
2
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Description
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Control group: Women with recurrent implant failure who use standard drugs (including: folic acid, vitamin D3, B complex and probiotics)
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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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Hamedan 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