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

A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells: A Randomized Controlled Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03792997
Enrollment
100
Registered
2019-01-04
Start date
2019-01-01
Completion date
2021-12-10
Last updated
2022-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unexplained Infertility

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

Interventions

COMBINATION_PRODUCTcombination therapy for high peripheral NK cells

lipid emulsion & prednisolone & LMWH

Sponsors

Hawaa Fertility Center
CollaboratorOTHER
Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 37 Years
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

Design outcomes

Primary

MeasureTime frameDescription
chemical pregnancy rate14 daysquantitative serum test

Secondary

MeasureTime frameDescription
clinical pregnancy rate6 weeks of pregnancygestational sac and fetal echo by ultrasound

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026