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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02854514
• Other study ID #: Khalid 2
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2016
• Last updated: November 20, 2016
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: November 2016
• Source: Benha University
• Contact: khalid M Salama, MD
• Phone: 01225861026
• Email: dr.khalid_sleem[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 37 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
Egypt	Benha university	Benha	Al qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Tumor Necrosis Factor (TNF)-a		2 days	Yes
Primary	Measurement of Interleukin (IL)-1b		2 days	Yes
Secondary	serum pregnancy test		14 days	Yes