NCT02854514

Brief Summary

For all women immediately after ovum retrieval from 80 women undergoing IVF, intra uterine salin flushing will be analyzed using a multiplex immunoassay for soluble regulators of implantation, namely Interleukin (IL)-1b, Tumor Necrosis Factor (TNF)-a,. In order to detect implantation predictors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

July 30, 2016

Last Update Submit

November 20, 2016

Conditions

Infertility

Keywords

endometrial -cytokines

Outcome Measures

Primary Outcomes (2)

  • Measurement of Tumor Necrosis Factor (TNF)-a

    2 days

  • Measurement of Interleukin (IL)-1b

    2 days

Secondary Outcomes (1)

  • serum pregnancy test

    14 days

Study Arms (1)

aspiration of endometrial secretion

intra uterine flushing of the endometrial cavity by five millilitre of saline through embryo transfer catheter then aspirated with endometrial secretion then centrifuged then analyzed for detection of concentration of tumor necrosis factor a and interleukin 1 b

Procedure: Aspiration of endometrial secretion

Interventions

Aspiration of endometrial secretionPROCEDURE

intra uterine flushing of the endometrial cavity by five millilitre of saline through embryo transfer catheter then aspirated then centrifuged then analyzed for detection of concentration of tumor necrosis factor a and interleukin 1 b

aspiration of endometrial secretion

Eligibility Criteria

Age20 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients undergoing IVF

You may qualify if:

  • Age younger than 37 years.
  • Having a regular and proven ovulatory menstrual cycles with a length of 26-35 days.
  • Body mass index less than 35 kg/m2.
  • Serum follicle stimulating hormone and estradiol were within normal ranges.

You may not qualify if:

  • Gross uterine pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha university

Banhā, Al Qalubia, Egypt

RECRUITING

Related Publications (2)

  • Boomsma CM, Kavelaars A, Eijkemans MJ, Amarouchi K, Teklenburg G, Gutknecht D, Fauser BJ, Heijnen CJ, Macklon NS. Cytokine profiling in endometrial secretions: a non-invasive window on endometrial receptivity. Reprod Biomed Online. 2009 Jan;18(1):85-94. doi: 10.1016/s1472-6483(10)60429-4.

    PMID: 19146774BACKGROUND

  • Salama KM, Alloush MK, Al Hussini RM. Are the cytokines TNF alpha and IL 1Beta early predictors of embryo implantation? Cross sectional study. J Reprod Immunol. 2020 Feb;137:102618. doi: 10.1016/j.jri.2019.102618. Epub 2019 Oct 17.

    PMID: 31698104DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • khalid M salama, MD

    Benha University

    STUDY DIRECTOR

Central Study Contacts

khalid M Salama, MD

CONTACT

01225861026dr.khalid_sleem@yahoo.com

Mohammed k Aloush, MD

CONTACT

01003541188mohamedkaloush@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director clinical research

Study Record Dates

First Submitted

July 30, 2016

First Posted

August 3, 2016

Study Start

April 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)