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NCT02752568 Clinical Trial

Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure

Recurrent Implantation Failure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02752568
Other study ID # ivfobgyn
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 25, 2016
Last updated April 26, 2016
Start date May 2016
Est. completion date December 2016

Study information
Verified date April 2016
Source Kasr El Aini Hospital
Contact suzy abdelaziz, lecturer
Phone 01003726195
Email suzyabdelaziz92@gmail.com
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date December 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• endometrial scratch
midluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation
• assisted hatching
using Octax laser 20120644-laser 5452
• controlled ovarian hyperstimulation
using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kasr El Aini Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary number of patients with positive pregnancy test 2 months No
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