Effect of Dilatation and Curettage on the Endometrial Receptivity
Primary Purpose
Embryo Implantation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
D&C
ICSI
Sponsored by
About this trial
This is an interventional treatment trial for Embryo Implantation
Eligibility Criteria
Inclusion Criteria:
- All the patients had at least 3 failed trials of IVF-ET with day 5 fresh blastocyst transferred
- At least 10 high-grade embryos were obtained in the previous trials
- Level of AMH more than or equal 1.1 ng/ml.
- Age: Less than or equal to 35 years
Exclusion Criteria:
- Patients with uterine pathology e.g. myoma , Asherman syndrome, Septum ,adenomyosis
- Hydrosalpinx
- Endometriosis
- patients with diagnosed autoimmune diseases affecting pregnancy e.g. S.L.E.
Sites / Locations
- Ain Shams University Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
D&C
No D&C
Arm Description
Outcomes
Primary Outcome Measures
Live Birth Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03485235
Brief Title
Effect of Dilatation and Curettage on the Endometrial Receptivity
Official Title
Effect of Dilatation and Curettage on the Endometrial Receptivity and Pregnancy Outcome in Patients With Recurrent Implantation Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 31, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Effect of dilatation and curettage on the endometrial receptivity and pregnancy outcome in patients with recurrent implantation failure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embryo Implantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D&C
Arm Type
Experimental
Arm Title
No D&C
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
D&C
Intervention Description
Dilatation and curettage
Intervention Type
Procedure
Intervention Name(s)
ICSI
Intervention Description
Intra Cytoplasmic Sperm Injection
Primary Outcome Measure Information:
Title
Live Birth Rate
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All the patients had at least 3 failed trials of IVF-ET with day 5 fresh blastocyst transferred
At least 10 high-grade embryos were obtained in the previous trials
Level of AMH more than or equal 1.1 ng/ml.
Age: Less than or equal to 35 years
Exclusion Criteria:
Patients with uterine pathology e.g. myoma , Asherman syndrome, Septum ,adenomyosis
Hydrosalpinx
Endometriosis
patients with diagnosed autoimmune diseases affecting pregnancy e.g. S.L.E.
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effect of Dilatation and Curettage on the Endometrial Receptivity
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