Endometrial Injury and Implantation Rates Before First ICSI Cycle

Study Overview
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Brief Summary
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Midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix, the step that will be beneficial to embryo transfer procedure. Controller ovarian hyperstimulation; will be done using the long luteal phase agonist protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3 FSH and antral follicular count and previous history of ovarian response). Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when there is >=1 follicle >=18 mm. and >=3 follicles >=16 mm. Ultasound guided oocyte retrieval will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3 after oocyt retrieval according to number and quality of embryos. Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.

Official Title
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Does Local Endometrial Injury Improve Implantation Rates in Women Undergoing Their First ICSI Cycle.

Conditions
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Invitro Fertilization

Intervention / Treatment
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* Procedure: Endometrial scratch injury


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subfertile women indicated for ICSI. normal uterine cavity demonstrated by transvaginal ultrasound and hystrogram. FSH<10mIU/mL on day 3 of her cycle. Exclusion Criteria: presence of endometrial polyp or fibroid distorting the uterine cavity. hydrosalpinx. ICSI carried out for preimplantation genetic diagnosis. FSH>10mIU\mL.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: endometrial scratch injury<br>endometrial scratch done before ICSI cycle | Procedure: Endometrial scratch injury<br>* midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix<br>|
| No Intervention: control<br>IcSI cycle without prior endometrial injury | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | number of sacs identifiable through ultrasonography divided by the number of embryos transferred | 14 days after embryo transfer | 
| clinical pregnancy rate | the detection of fetal cardiac activity within a gestational sac on ultrasonography examination | 4 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| multiple pregnancy rate | number of patients who had a multifetal pregnancy divided by the total number of clinical pregnancies | 4 weeks after embryo transfer | 
| abortion rate | number of patients who had a spontaneous abortion before 12 weeks of pregnancy divided by total number of clinical pregnancies | 12 weeks of gestational age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICSI, endometrial injury, implantation rate