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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN61316186 |
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Date of registration:
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22/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Endometrial injury prior to first cycle IVF/ICSI
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Scientific title:
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The effect of endometrial injury on first cycle IVF/ICSI outcome: a randomized controlled trial. |
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Date of first enrolment:
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01/06/2012 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN61316186 |
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Study type:
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Interventional |
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Study design:
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Randomized controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Ahmad
Mahran |
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Address:
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Department of Obstetrics and Gynecology
Faculty of Medicine
Minia University
61111
Minia
Egypt |
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Telephone:
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00201115551073 |
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Email:
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ezzeldin_ahmad@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age between 20-40 years
2. FSH = 12
3. Normal uterine cavity by hysteroscopy (done routinely for all cases prior to ICSI)
4. = 2 good quality embryos replaced
Exclusion criteria: 1. Age > 40 years
2. Abnormal uterine cavity due to submucous fibroid, endometrial polyps, Asherman’s syndrome or congenital uterine malformations
3. Patients who have < 2 good quality embryos at time of transfer were excluded from the analysis
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Outcome of IVF / ICSI cycles.
Pregnancy and Childbirth
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Intervention(s)
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Endometrial scratch performed in the cycle preceding the IVF/ICSI cycle
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Primary Outcome(s)
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1. Live birth rate; calculated as the ration of number of patients with live births divided by the number of patients who had embryo transfer
2. Implantation rate; calculated as number of gestational sacs evident by ultrasound divided by the number of transferred embryos
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Secondary Outcome(s)
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1. Clinical pregnancy rate; calculated as the number of patients with clinical pregnancy divided by the number of patients who had embryo transfer
2. Miscarriage rate per clinical pregnancy; calculated as the number of patients who had miscarriage divided by the number of patients who had clinical pregnancies
3. Multiple gestations rate; calculated as the number of patients who had multiple gestation divided by the number of patients who had clinical pregnancies
4. Pain; reported pain during the intervention
5. Bleeding; reports of abnormal bleeding during or after the intervention
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Secondary ID(s)
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153052012
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Source(s) of Monetary Support
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Department of Obstetrics and Gynecology, Faculty of Medicine, Minia University, Minia, Egypt
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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