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

• Conditions: Infertility
• Interventions: Procedure: Aspiration of endometrial secretion

• Registration Number: NCT02854514
• Lead Sponsor: Benha University

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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-07-30
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-20
• Last Update Posted: 2016-11-22
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Read More

Exclusion Criteria

• Gross uterine pathology.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
aspiration of endometrial secretion	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

Primary Outcome Measures

Name	Time	Method
Measurement of Tumor Necrosis Factor (TNF)-a	2 days
Measurement of Interleukin (IL)-1b	2 days

Secondary Outcome Measures

Name	Time	Method
serum pregnancy test	14 days

Trial Locations

Locations (1)

Benha university; 🇪🇬 Benha, Al qalubia, Egypt