A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Benha University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- chemical pregnancy rate
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 37 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
control
regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid
Intervention: combination therapy for high peripheral NK cells (Combination Product)
study
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: combination therapy for high peripheral NK cells (Combination Product)
Outcomes
Primary Outcomes
chemical pregnancy rate
Time Frame: 14 days
quantitative serum test
Secondary Outcomes
- clinical pregnancy rate(6 weeks of pregnancy)
Investigators
Ahmed Saad
Assistant professor of Ob. & Gyn.
Benha University