Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure
April 26, 2016 updated by: suzy abdelaziz Abdelhamid, Kasr El Aini Hospital
Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure.A Comparative Study
300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Endometrial scratch group
endometrial scratch controlled ovarian hyperstimulation
|
midluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation
Other Names:
using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol
|
|
Active Comparator: Assisted hatching group
assisted hatching controlled ovarian hyperstimulation
|
using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol
using Octax laser 20120644-laser 5452
Other Names:
|
|
Sham Comparator: ovarian stimulation only group
controlled ovarian hyperstimulation
|
using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of patients with positive pregnancy test
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: suzy abdelaziz, lecturer, kasrelaini hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Anticipated)
November 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
April 25, 2016
First Submitted That Met QC Criteria
April 26, 2016
First Posted (Estimate)
April 27, 2016
Study Record Updates
Last Update Posted (Estimate)
April 27, 2016
Last Update Submitted That Met QC Criteria
April 26, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ivfobgyn
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.