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

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT03792997
Collaborator
Hawaa Fertility Center (Other)
100
Enrollment
1
Location
2
Arms
35.3
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Combination Product: combination therapy for high peripheral NK cells
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells: A Randomized Controlled Trial
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Dec 15, 2019
Actual Study Completion Date :
Dec 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. chemical pregnancy rate [14 days]

    quantitative serum test

Secondary Outcome Measures

  1. clinical pregnancy rate [6 weeks of pregnancy]

    gestational sac and fetal echo by ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 37 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banha University- Hawaa Fertility center Banha Qalyubiya Egypt 13512

Sponsors and Collaborators

  • Benha University
  • Hawaa Fertility Center

Investigators

  • Principal Investigator: ahmed sa saad, MD, ph D, Hawaa Fertility Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Saad, Assistant professor of Ob. & Gyn., Benha University
ClinicalTrials.gov Identifier:
NCT03792997
Other Study ID Numbers:
  • Hawaa-6
First Posted:
Jan 4, 2019
Last Update Posted:
Jan 3, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility

Study Results

No Results Posted as of Jan 3, 2022