Clinical trial NCT02854514: Predictive Value of Endometrial Cytokines in Endometrial Implantation in Cases of Intracytoplasmic Sperm Injection
Official title: Predictive Value of Endometrial Cytokines in Endometrial Implantation in Cases of Intracytoplasmic Sperm Injection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: endometrial -cytokines
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing IVF

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of Tumor Necrosis Factor (TNF)-a
timeFrame: 2 days
measure: Measurement of Interleukin (IL)-1b
timeFrame: 2 days
Secondary outcomes:
measure: serum pregnancy test
timeFrame: 14 days
Other outcomes:
Locations:
city: Benha
country: Egypt
facility: Benha university
state: Al qalubia
Study officials:
affiliation: Benha University
name: khalid M salama, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.