Back to resultsPhysical Endometrial Manipulation and Its Effect on ICSI
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hydrotubation
Sponsored by
About this trial
This is an interventional health services research trial for Infertility focused on measuring ICSI - physical - Manipulation - scratching
Eligibility Criteria
Inclusion Criteria:
- Infertile female age 20-35 years
- Previous Failed one ICSI trial
- normal basal hormonal profile [FSH, LH] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively, --normal endometrial cavity
- patent tubes
- normal Husband semen analysis
Exclusion Criteria:
- Ovarian factor of infertility
- Tubal factor of infertility
- Endometrial factor of infertility
- Male factor of infertility
Sites / Locations
- Algazeerah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
manipulation of endometrium
no manipulation to endometrium in ICSI
Arm Description
The arm is physical manipulation to the endometrium prior to ICSI By one of these interventions )Hydrotubation , Sonohysterography or endometrial scratching
This is the control group , with no manipulation to endometrium prior to ICSI No intervention to this group
Outcomes
Primary Outcome Measures
The number of participants who achieved clinical pregnancy
Describes how many participant will continue pregnancy after positive pregnancy test
Secondary Outcome Measures
The number of participants who achieved ongoing pregnancy and live birth
Describes who many participant will continue pregnancy till he had birth and a live birth
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03345251
Brief Title
Physical Endometrial Manipulation and Its Effect on ICSI
Official Title
Physical Endometrial Manipulation and Its Effect on Success Rate in Patients With Previous ICSI Failure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
December 25, 2017 (Actual)
Study Completion Date
December 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aljazeera Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility . Implantation is the main rate limiting step in IVF outcome. Implantation is described at cellular and molecular level by adhesion or fixation of good quality embryo to receptive endometrium within a critical period of time which is called the window of implantation .
Detailed Description
Testing the effect of Physical manipulation of the endometrium on the quality of the endometrium prior to ICSI cycle and if it increases the success rate
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ICSI - physical - Manipulation - scratching
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
640 were enrolled but 608 were analyzed
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
640 (Actual)
8. Arms, Groups, and Interventions
Arm Title
manipulation of endometrium
Arm Type
Experimental
Arm Description
The arm is physical manipulation to the endometrium prior to ICSI By one of these interventions )Hydrotubation , Sonohysterography or endometrial scratching
Arm Title
no manipulation to endometrium in ICSI
Arm Type
Placebo Comparator
Arm Description
This is the control group , with no manipulation to endometrium prior to ICSI No intervention to this group
Intervention Type
Device
Intervention Name(s)
Hydrotubation
Other Intervention Name(s)
Sonohysterography, Endometrial scratching
Primary Outcome Measure Information:
Title
The number of participants who achieved clinical pregnancy
Description
Describes how many participant will continue pregnancy after positive pregnancy test
Time Frame
6 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
The number of participants who achieved ongoing pregnancy and live birth
Description
Describes who many participant will continue pregnancy till he had birth and a live birth
Time Frame
9 months after embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Infertile female age 20-35 years
Previous Failed one ICSI trial
normal basal hormonal profile [FSH, LH] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively, --normal endometrial cavity
patent tubes
normal Husband semen analysis
Exclusion Criteria:
Ovarian factor of infertility
Tubal factor of infertility
Endometrial factor of infertility
Male factor of infertility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Organizational Affiliation
Algazeerah hospital -Location (Giza -Egypt )
Official's Role
Study Chair
Facility Information:
Facility Name
Algazeerah
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physical Endometrial Manipulation and Its Effect on ICSI
We'll reach out to this number within 24 hrs