Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure

Study Overview
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Brief Summary
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300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group

Detailed Description
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Group 1 consists of 100 patients will undergo endometrial scratch followed by controlled ovarian hyperstimulation Group 2 consists of 100 patients will undergo controlled ovarian hyperstimulation& assisted hatching Group 3 consists of 100 patients will undergo controlled ovarian hyperstimulation

Official Title
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Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure.A Comparative Study

Conditions
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Recurrent Implantation Failure

Intervention / Treatment
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* Procedure: endometrial scratch
* Procedure: assisted hatching
* Procedure: controlled ovarian hyperstimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: recurrent implantation failure normal uterine cavity by transvaginal ultrasound Exclusion Criteria: endometrial polyp or fibroid distorting the endometrium hydrosalpinx preimplantation genetic diagnosis severe male factor

Ages Eligible for Study
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Minimum Age: 18 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endometrial scratch group<br>endometrial scratch controlled ovarian hyperstimulation | Procedure: endometrial scratch<br>* midluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation<br>* Other names: endometrial injury;Procedure: controlled ovarian hyperstimulation<br>* using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol<br>|
| Active Comparator: Assisted hatching group<br>assisted hatching controlled ovarian hyperstimulation | Procedure: assisted hatching<br>* using Octax laser 20120644-laser 5452<br>* Other names: laser hatching;Procedure: controlled ovarian hyperstimulation<br>* using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol<br>|
| Sham Comparator: ovarian stimulation only group<br>controlled ovarian hyperstimulation | Procedure: controlled ovarian hyperstimulation<br>* using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with positive pregnancy test |  | 2 months |