Back to resultsA Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells
Primary Purpose
Unexplained Infertility
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
combination therapy for high peripheral NK cells
Sponsored by
About this trial
This is an interventional treatment trial for Unexplained Infertility
Eligibility Criteria
Inclusion Criteria:
- patients with high peripheral NK cells > 10% unexplained infertility cases cases with endometriosis
Exclusion Criteria:
- uterine factors poor responders< 3 MII oocytes severe male factor & Azospermia
Sites / Locations
- Banha University- Hawaa Fertility center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control
study
Arm Description
regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid
regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid but the investigators add in this arm lipid emulsion & prednisolone & LMWH
Outcomes
Primary Outcome Measures
chemical pregnancy rate
quantitative serum test
Secondary Outcome Measures
clinical pregnancy rate
gestational sac and fetal echo by ultrasound
Full Information
NCT ID
NCT03792997
First Posted
January 2, 2019
Last Updated
December 13, 2021
Sponsor
Benha University
Collaborators
Hawaa Fertility Center
1. Study Identification
Unique Protocol Identification Number
NCT03792997
Brief Title
A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells
Official Title
A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
Collaborators
Hawaa Fertility Center
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
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion &prednisolone & LMWH
Detailed Description
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion begin in the cycle before embryo transfer &prednisolone begin with the start of lipid emulsion & LMWH begin with the day of ET
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid
Arm Title
study
Arm Type
Experimental
Arm Description
regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid but the investigators add in this arm lipid emulsion & prednisolone & LMWH
Intervention Type
Combination Product
Intervention Name(s)
combination therapy for high peripheral NK cells
Intervention Description
lipid emulsion & prednisolone & LMWH
Primary Outcome Measure Information:
Title
chemical pregnancy rate
Description
quantitative serum test
Time Frame
14 days
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Description
gestational sac and fetal echo by ultrasound
Time Frame
6 weeks of pregnancy
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Infertile females undergoing ART cycles
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with high peripheral NK cells > 10% unexplained infertility cases cases with endometriosis
Exclusion Criteria:
uterine factors poor responders< 3 MII oocytes severe male factor & Azospermia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed sa saad, MD, ph D
Organizational Affiliation
Hawaa Fertility Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha University- Hawaa Fertility center
City
Banha
State/Province
Qalyubiya
ZIP/Postal Code
13512
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
study protocol, statistical analysis & results
IPD Sharing Time Frame
1 month after publication, for 6 months
IPD Sharing Access Criteria
for researchers doing metanalysis.by contacting us by email
Learn more about this trial
A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells
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