NCT03361839

Brief Summary

clinical trial to improve pregnancy outcome in patient with RLF , study done on 2 phases. phase 1 to study variations of endometrial receptivity genes in this group of patient, phase 2 repeat cycle or transfer frozen embryo in proper time and after giving proper treatment

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2017

Status
unknown

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

First Submitted

Initial submission to the registry

November 18, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

11 months

First QC Date

November 18, 2017

Last Update Submit

December 1, 2017

Conditions

RIF , Endometrial Receptivity

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    positive intrauterine sac

    two weeks after transfer

Study Arms (2)

1

ACTIVE COMPARATOR

patients with RIF

Diagnostic Test: endometrial biopsy

2

PLACEBO COMPARATOR

fertile arm as r reference for result

Diagnostic Test: endometrial biopsy

Interventions

endometrial biopsyDIAGNOSTIC_TEST

endometrial biopsy for genetic study of endometrial receptivity

12

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with history of recurrent implantation failure with History of transfer of at least 4 good quality embryos in at least 3 fresh or frozen cycles
  • Women age less than 40 years • BMI (25 - 33)

You may not qualify if:

  • diabetic women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nejat EJ, Ruiz-Alonso M, Simon C, Meier UT. Timing the window of implantation by nucleolar channel system prevalence matches the accuracy of the endometrial receptivity array. Fertil Steril. 2014 Nov;102(5):1477-81. doi: 10.1016/j.fertnstert.2014.07.1254. Epub 2014 Sep 17.

    PMID: 25241377BACKGROUND

Study Officials

  • abdelmegeed ramzy, professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

olfat ali, professor

CONTACT

01011866550olfat_noh@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: non randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 18, 2017

First Posted

December 5, 2017

Study Start

December 1, 2017

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

December 5, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

net results data