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NCT03792997 Clinical Trial

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

Unexplained Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03792997
Other study ID # Hawaa-6
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 1, 2019
Est. completion date December 10, 2021

Study information
Verified date December 2021
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 10, 2021
Est. primary completion date December 15, 2019
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 37 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• combination therapy for high peripheral NK cells
lipid emulsion & prednisolone & LMWH

Locations
Country Name City State
Egypt Banha University- Hawaa Fertility center Banha Qalyubiya

Sponsors (2)
Lead Sponsor Collaborator
Benha University Hawaa Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary chemical pregnancy rate quantitative serum test 14 days
Secondary clinical pregnancy rate gestational sac and fetal echo by ultrasound 6 weeks of pregnancy
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