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

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

Study Overview

• Status: Completed
• Conditions: Unexplained Infertility
• Intervention / Treatment: Combination product: combination therapy for high peripheral NK cells

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Qalyubiya
    • Banha, Qalyubiya, Egypt, 13512
      • Banha University- Hawaa Fertility center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid	Combination product: combination therapy for high peripheral NK cells; lipid emulsion & prednisolone & LMWH
Experimental: 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	Combination product: combination therapy for high peripheral NK cells; lipid emulsion & prednisolone & LMWH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemical pregnancy rate	quantitative serum test	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	gestational sac and fetal echo by ultrasound	6 weeks of pregnancy

Collaborators and Investigators

• Sponsor: Benha University
• Collaborators: Hawaa Fertility Center
• Investigators: Principal Investigator: ahmed sa saad, MD, ph D, Hawaa Fertility Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Hawaa-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: study protocol, statistical analysis & results
• IPD Sharing Time Frame: 1 month after publication, for 6 months
• IPD Sharing Access Criteria: for researchers doing metanalysis.by contacting us by email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No