NCT03792997

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

12 months

First QC Date

January 2, 2019

Last Update Submit

December 13, 2021

Conditions

Unexplained Infertility

Outcome Measures

Primary Outcomes (1)

  • chemical pregnancy rate

    quantitative serum test

    14 days

Secondary Outcomes (1)

  • clinical pregnancy rate

    6 weeks of pregnancy

Study Arms (2)

control

ACTIVE COMPARATOR

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

study

EXPERIMENTAL

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

Interventions

combination therapy for high peripheral NK cellsCOMBINATION_PRODUCT

lipid emulsion \& prednisolone \& LMWH

controlstudy

Eligibility Criteria

Age20 Years - 37 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsInfertile females undergoing ART cycles
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with high peripheral NK cells \> 10% unexplained infertility cases cases with endometriosis

You may not qualify if:

  • uterine factors poor responders\< 3 MII oocytes severe male factor \& Azospermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha University- Hawaa Fertility center

Banhā, Qalyubia Governorate, 13512, Egypt

Location

MeSH Terms

Interventions

Combined Modality Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • ahmed sa saad, MD, ph D

    Hawaa Fertility Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Ob. & Gyn.

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 4, 2019

Study Start

January 1, 2019

Primary Completion

December 15, 2019

Study Completion

December 10, 2021

Last Updated

January 3, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

study protocol, statistical analysis \& results

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
1 month after publication, for 6 months
Access Criteria
for researchers doing metanalysis.by contacting us by email

Locations

EG(1)