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

NCT ID: NCT03792997

Last Updated: 2022-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-12-10

Brief Summary

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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

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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

Conditions

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Unexplained Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

regular treatment with embryo transfer in the form of progesterone I.M. \& Supp. in addition to low dose aspirin \& folic acid

Group Type ACTIVE_COMPARATOR

combination therapy for high peripheral NK cells

Intervention Type COMBINATION_PRODUCT

lipid emulsion \& prednisolone \& LMWH

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

Group Type EXPERIMENTAL

combination therapy for high peripheral NK cells

Intervention Type COMBINATION_PRODUCT

lipid emulsion \& prednisolone \& LMWH

Interventions

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combination therapy for high peripheral NK cells

lipid emulsion \& prednisolone \& LMWH

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hawaa Fertility Center

OTHER

Sponsor Role collaborator

Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Saad

Assistant professor of Ob. & Gyn.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed sa saad, MD, ph D

Role: PRINCIPAL_INVESTIGATOR

Hawaa Fertility Center

Locations

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Banha University- Hawaa Fertility center

Banhā, Qalyubia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Hawaa-6

Identifier Type: -

Identifier Source: org_study_id

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