Protocol summary
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Study aim
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Assess the effect of endometrial incision in the fundus of the uterine on the success rate of IVF in infertile women with at least one failed IVF/ICSI cycle.
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Design
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Phase 3 clinical trial with a control group, parallel design, using the random allocation rule is performed on 500 patients.
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Settings and conduct
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In the operating room of Yas Hospital, Tehran, this randomized trial included a control group (endometrial scraping with biopsy forceps) and a case (fundus cut with scissors) of patient blinding on 500 IVF candidate patients in Yas Hospital, selected by available sampling. are entering the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include infertile women candidates for IVF with at least one failed IVF/ICSI cycle. aged 20 to 42 years, with a body mass index of less than 30 kg/m2, and having at least 3 grade A or B fetuses. Exclusion Criteria: Presence of uterine anomaly, submucosal leiomyoma, and endometrial polyp.
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Intervention groups
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The intervention group undergoes hysteroscopy on one of the days 18-24 of the cycle before embryo transfer, and a small incision is made in the uterine fundus with hysteroscopic scissors, while endometrial crushing by biopsy forcepse is done for the control group. After estradiol therapy frozen embryo transfer will be scheduled.
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Main outcome variables
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Biochemical pregnancy, and clinical pregnancy
General information
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Reason for update
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Due to the need to change some processes during the trial, these changes should be recorded and approved.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20091012002576N21
Registration date:
2021-08-22, 1400/05/31
Registration timing:
prospective
Last update:
2024-08-21, 1403/05/31
Update count:
1
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Registration date
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2021-08-22, 1400/05/31
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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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2021-09-23, 1400/07/01
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Expected recruitment end date
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2021-11-22, 1400/09/01
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Actual recruitment start date
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2021-10-20, 1400/07/28
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Actual recruitment end date
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2022-09-01, 1401/06/10
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Trial completion date
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2022-10-22, 1401/07/30
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Scientific title
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Evaluation the effect of endometrial incision in the fundus of uterine on the success rate of IVF in infertile women with at least one failed IVF/ICSI cycle.
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Public title
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Endometrial incision in the fundus of uterine and the success rate of assisted reproductive technique
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Body mass index lower than 30
Having at least 3 grade A or B fetuses
Infertile women with at least one failed IVF/ICSI cycle
Exclusion criteria:
Uterine anomaly
Sub mucosal leiomyoma
Endometrial polyp
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Age
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From 20 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:
500
Actual sample size reached:
500
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation rule: First, 250 letters A and 250 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (endometrial incision) or B (control group,crushing endometriumwithbiopsy forceps) are determined by a lot.
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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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2021-08-17, 1400/05/26
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1400.556
Health conditions studied
1
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Description of health condition studied
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Female 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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Biochemical pregnancy
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Timepoint
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Two weeks after embryo transfer
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Method of measurement
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Blood sampling
Secondary outcomes
1
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Description
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Clinical pregnancy
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Timepoint
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Four weeks after embryo transfer
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Method of measurement
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Fetal heart activity in transvaginal sonogram
Intervention groups
1
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Description
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Intervention group: Patients undergo hysteroscopy on one of the days 18-24 of the cycle before embryo transfer, and a small incision is made in the uterine fundus with hysteroscopic scissors. To start the transfer cycle, all participants are advised to refer on days 2 to 3 of the cycle. Then, on the second or third day of the menstrual cycle, 6 mg oral estradiol ( Abu Reihan Pharmaceutical Company) is prescribed daily. Simultaneously, the initial evaluation of vaginal ultrasound is performed to examine the ovaries and the endometrium thickness. after 4 days, the ultrasound will be repeated and the dose of the drug will be adjusted. In serial vaginal ultrasound, after the endometrial thickness reaches 8 mm, 100 mg progesterone (Iran Hormone Pharmaceutical Company) is prescribed daily, on the 4th day of progesterone initiation, two or three grade A or B embryos will be transferred under an ultrasound guide with a COOk catheter.
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Category
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Treatment - Surgery
2
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Description
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Control group: Patients undergo hysteroscopy on one of the days 18-24 of the cycle before embryo transfer, and endometrial crushing by biopsy forceps willbedonec. To start the transfer cycle, all participants are advised to refer on days 2 to 3 of the cycle. Then, on the second or third day of the menstrual cycle, 6 mg oral estradiol ( Abu Reihan Pharmaceutical Company) is prescribed daily. Simultaneously, the initial evaluation of vaginal ultrasound is performed to examine the ovaries and the endometrium thickness. after 4 days, the ultrasound will be repeated and the dose of the drug will be adjusted. In serial vaginal ultrasound, after the endometrial thickness reaches 8 mm, 100 mg progesterone (Iran Hormone Pharmaceutical Company) is prescribed daily, on the 4th day of progesterone initiation, two or three grade A or B embryos will be transferred under an ultrasound guide with a COOk catheter.
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Category
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Treatment - Surgery
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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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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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data is potentially shareable after unidentified participants
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When the data will become available and for how long
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After manuscript published
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To whom data/document is available
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No limitations
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Under which criteria data/document could be used
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The data is only available to the project manager, Dr. Davari, and any analysis must be done with her opinion.
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From where data/document is obtainable
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Dr. Davari through email (fdavaritanha@sina.tums.ac.ir)
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What processes are involved for a request to access data/document
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Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Davari.
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Comments
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