Predictive Value of Endometrial Cytokines in Endometrial Implantation in Cases of Intracytoplasmic Sperm Injection

November 20, 2016 updated by: khalid mohammed salama, Benha University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective cohort study, performed on 80 women attending Obstetrics and Gynecology Department of Benha University Hospital for invitro fertilization/intracytoplasmic sperm injection treatment and private IVF centers. None undergoes more than one prior unsuccessful embryo transfer.

Method of randomization:

Simple random sample, which is a subset of individuals (a sample) chosen from a larger set (a population). Each individual is chosen randomly and entirely by chance, so each individual has the sample probability of being chosen at any stage during the sampling process, and each subset of k individuals has the same probability of being chosen for the sample as any other subset of k individuals (Yates et al., 2008).

Methods:

The patients will be subjected to the following:

  • History.
  • General examination.
  • Endometrial secretion aspiration.
  • Determination of the cytokine profile.
  • Detection of implantation rate.

Inclusion criteria:

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

Indications of IVF:

Tubal pathology, unexplained infertility, and male factor.

Exclusion criteria:

Gross uterine pathology.

Steps of performance:

All women having the inclusion criteria were subjected to super ovulation protocols followed by hcg adminstration when the follicles reached 18-20 mm . Ovum retrieval were done at 35 hours following hcg injection.

Five millilitre of salin are injected intrauterine then aspirated after ovum retrieval.Endometrial secretions, aspirated immediately after ovum retrieval from 80 women undergoing IVF, 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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al qalubia
      • Benha, Al qalubia, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

patients undergoing IVF

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Gross uterine pathology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of Tumor Necrosis Factor (TNF)-a
Time Frame: 2 days
2 days
Measurement of Interleukin (IL)-1b
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
serum pregnancy test
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Study Director: khalid M salama, MD, Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

July 30, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 20, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Khalid 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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