InfertilityNCT02854514
Predictive Value of Endometrial Cytokines in Endometrial Implantation in Cases of Intracytoplasmic Sperm Injection
An observational study of Infertility, run by Benha University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Aspiration of endometrial secretion
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Study population: patients undergoing IVF
Who may be able to join
- Age younger than 37 years.
- Having a regular and proven ovulatory menstrual cycles with a length of 26-35 days.
- Body mass index less than 35 kg/m2.
- Serum follicle stimulating hormone and estradiol were within normal ranges.
Who cannot join
- Gross uterine pathology.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benha university
Banhā, Al Qalubia
M k Aloush, 01003541188, mohamedkaloush@gmail.com
About this study
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.
Read the 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:
- Age younger than 37 years.
- Having a regular and proven ovulatory menstrual cycles with a length of 26-35 days.
- Body mass index less than 35 kg/m2.
- 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
- Infertility
- Being tested
- Aspiration of endometrial secretion
- Keywords
- endometrial -cytokines
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration of endometrial secretionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Aspiration of endometrial secretion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Tumor Necrosis Factor (TNF)-a
Measured: 2 days
Measurement of Interleukin (IL)-1b
Measured: 2 days
Secondary outcomes (1)
serum pregnancy test
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startApr 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalid mohammed salama, Benha University
- Investigators
- khalid M salama, MD, Study director, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854514
- Sponsor's protocol ID
- Khalid 2
- Status last verified
- Nov 2016
- First submitted
- 30 Jul 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19146774Salama 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.
PubMed 31698104
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Endometrial Cytokines in Endometrial Implantation in Cases of Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT02854514
- Acronym / sponsor ID
- Khalid 2
- Conditions
- Infertility
- Keywords
- endometrial -cytokines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Age younger than 37 years.
- Having a regular and proven ovulatory menstrual cycles with a length of 26-35 days.
- Body mass index less than 35 kg/m2.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aspiration of endometrial secretion | – | Procedure: Aspiration of endometrial secretionintra 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 |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients undergoing IVF
Key inclusion criteria (4 listed)
- Age younger than 37 years.
- Having a regular and proven ovulatory menstrual cycles with a length of 26-35 days.
- Body mass index less than 35 kg/m2.
- Serum follicle stimulating hormone and estradiol were within normal ranges.
Key exclusion criteria (1 listed)
- Gross uterine pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspiration of endometrial secretionintra 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 | Procedure or surgery | aspiration of endometrial secretion |
Primary outcome
Measurement of Tumor Necrosis Factor (TNF)-a
Time frame: 2 days
Measurement of Interleukin (IL)-1b
Time frame: 2 days
1 secondary outcome
serum pregnancy test
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Background: PubMed 19146774Boomsma 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.
- Derived from this study: PubMed 31698104Salama 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
khalid M salama, MD study director
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact khalid M Salama, MD (01225861026, dr.khalid_sleem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Tumor Necrosis Factor (TNF)-a (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02854514, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.