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

Phase 2

Completed

• Conditions: Unexplained Infertility
• Interventions: Combination Product: combination therapy for high peripheral NK cells

• Registration Number: NCT03792997
• Lead Sponsor: Benha University

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 Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-04
• Primary Completion: 2019-12-15
• Status Verified: 2021-12
• Study Completion: 2021-12-10
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	combination therapy for high peripheral NK cells	regular treatment with embryo transfer in the form of progesterone I.M. \& Supp. in addition to low dose aspirin \& folic acid
study	combination therapy for high peripheral NK cells	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

Primary Outcome Measures

Name	Time	Method
chemical pregnancy rate	14 days	quantitative serum test

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rate	6 weeks of pregnancy	gestational sac and fetal echo by ultrasound

Trial Locations

Locations (1)

Banha University- Hawaa Fertility center; 🇪🇬 Banha, Qalyubiya, Egypt