Predictive Value of Endometrial Cytokines in Endometrial Implantation in Cases of Intracytoplasmic Sperm Injection
NCT ID: NCT02854514
Last Updated: 2016-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2015-04-30
2017-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
20 Years
37 Years
FEMALE
No
Sponsors
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Benha University
OTHER
Responsible Party
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khalid mohammed salama
director clinical research
Principal Investigators
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khalid M salama, MD
Role: STUDY_DIRECTOR
Benha University
Locations
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Benha university
Banhā, Al Qalubia, Egypt
Countries
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Central Contacts
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Facility Contacts
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M k Aloush
Role: primary
References
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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.
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.
Other Identifiers
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Khalid 2
Identifier Type: -
Identifier Source: org_study_id