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Completed

NCT Number: NCT03792997

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

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

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Key information

Conditions

Unexplained Infertility

Age range

20 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Banha University- Hawaa Fertility center

Banhā, Qalyubia Governorate, 13512, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combination therapy for high peripheral NK cells

Combination Product

lipid emulsion & prednisolone & LMWH

Primary outcomes

  1. chemical pregnancy rate

    Time frame: 14 days

    quantitative serum test

Secondary outcomes

  1. clinical pregnancy rate

    Time frame: 6 weeks of pregnancy

    gestational sac and fetal echo by ultrasound

Sponsors and collaborators

Lead sponsor

Benha University

Other

Collaborators

  • Hawaa Fertility Center

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Jan 4, 2019
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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