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A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells

B

Benha University

Status and phase

Completed
Phase 2

Conditions

Unexplained Infertility

Treatments

Combination Product: combination therapy for high peripheral NK cells

Study type

Interventional

Funder types

Other

Identifiers

NCT03792997
Hawaa-6

Details and patient eligibility

About

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

Full 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

Enrollment

100 patients

Sex

Female

Ages

20 to 37 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

control
Active Comparator group
Description:
regular treatment with embryo transfer in the form of progesterone I.M. \& Supp. in addition to low dose aspirin \& folic acid
Treatment:
Combination Product: combination therapy for high peripheral NK cells
study
Experimental group
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
Treatment:
Combination Product: combination therapy for high peripheral NK cells

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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