Infertility, FemaleNCT03581617
Infections and Unexplained Infertility
An observational study of Infertility, Female, run by University Hospital of Ferrara.
Trial summary
1. Background: In women, unexplained infertility has been associated with a range of cellular and molecular defects in the endometrium, adverse immune responses and immunological factors. Natural killer (NK) cells are included as they constitute the most abundant leukocyte population in the decidua. Read more about this study
- Who is it for?
- Ages 21 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- NK cell analysis, Herpesvirus detection and sHLA-G analysis
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 1 Nov 2016
- 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 21 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This will be a prospective non-interventional clinical study, based on biological specimens sampled during current standard clinical practice. Based on our preliminary results, we will enroll 100 infertile and 30 control women to achieve a 0.8 power with 5% alpha error in detecting differences between infertile and fertile women.
Who may be able to join
- 21-38 years old,
- primary infertility (no live birth),
- regular menstrual cycle (24-35 days),
- body mass index (BMI) ≤ 25, FSH <10 mUI/mL,
- E2 < 50 pg/ml on day 2-3 of the menstrual cycle. Recruitment at admission for tubal patency assessment.
- 21-35 years old,
Show all 10Show fewer
- almost one live birth,
- regular menstrual cycle (24-35 days),
- BMI ≤ 25, FSH <10 mUI/mL,
- E2 < 50 pg/mL on day 2-3 of the menstrual cycle
Who cannot join
- endometritis,
- endometriosis,
- tubal factor,
- ovulatory dysfunction,
- anatomical uterine pathologies.
About this study
Official title: Prognostic Markers in Women With Primary Unexplained Infertility
- Background: In women, unexplained infertility has been associated with a range of cellular and molecular defects in the endometrium, adverse immune responses and immunological factors. Natural killer (NK) cells are included as they constitute the most abundant leukocyte population in the decidua. While decidua NK cells were extensively investigated, the study of endometrial eNK cells still lacks comprehensive researches. The reduction in eNK frequency has been associated with infertility status, in particular in the presence of a concomitant herpesvirus viremia. Since herpesviruses use as immune-escape HLA-G and HLA-E molecules, that are immune-inhibitory and important for a correct placentation, they could represent infertility co-factors.
- Aims: Since lack of an accurate diagnosis in reproductive medicine leads to treatment failure, this proposal focuses on eNK cell characterization as a diagnostic factor for unexplained women infertility. We will evaluate also co-factors, taking into consideration herpesvirus infection and HLA-G and HLA-E expression.
- Methods: Peripheral blood and endometrial NK cells will be immune-phenotyped and cell count and activation status (CD107a, IL-6, IL-10, IL-17) will be correlated with infertility condition. The implication of herpesvirus will be evaluated by DNA from peripheral blood and endometrial flushing samples analysis by HSV-1, HSV-2, EBV, CMV, HHV-6, HHV-7, VZV and HHV-8 specific primers an PCR technique. HLA-G and HLA-E expression will be analyzed in peripheral blood and endometrial environment by flow cytometry and ELISA tests and correlated by NK cell expression of their receptors (KIRs, LILRB1/2, NKG2A).
- Expected results: On the basis of our preliminary results, we expect to identify NK cells as prognostic marker for primary unexplained infertility, with herpesvirus infection and HLA-G and HLA-E expression as co-factors. These data will be of importance in the management of infertile women.
Read the detailed description
Primary Objective The main challenge of this project is to define the potential role of NK cells as a prognostic marker for primary unexplained infertility. To achieve this objective we will perform a prospective study on a cohort of 100 unexplained infertile women. Peripheral blood and endometrial NK cells will be immune phenotyped and their activation status will be analyzed. Meanwhile, the presence of herpesvirus infection will be evaluated in peripheral blood and correlated with the results of NK analysis. These data will clarify the role of NK cells in infertile female conditions, evaluating the implication of herpesvirus infection as a cofactor for NK cell status. These data will provide a proof of principle of the use of NK cell analysis as a predictive marker for unexplained infertility.
Secondary Objective The secondary objective is to evaluate the mechanisms at the basis of the NK cell status in infertility. Since HLA-G and HLA-E expression is modified by herpesvirus infection (9), as an immune escape mechanism, and these antigens are responsible of a correct embryo implantation (14), we will analyze the levels of these molecules in peripheral blood and endometrial environment. Meanwhile, HLA-G and HLA-E genetic polymorphisms will be analyzed. These results will be correlated with the presence of herpesvirus infection, KIR, LILRB and NKG2A receptor expression on pNK and eNK cells. These data will clarify the implication of HLA-G and HLA-E expression and genetic background in the control of NK cell activation and herpesvirus infection in infertile women.
The achievement of these objectives will be obtained with 6 workpackages/aims (WP)
- Infertile women characterization (WP1) (1-20mth) We will recruit 100 unexplained infertile women and 30 control women. These women will be clinically evaluated, establishing a clinical database. From each woman, we will obtain peripheral blood samples, endometrium biopsies, and uterine flushing.
- NK cell immune-phenotype (WP2) (1-20mth) NK cells from peripheral blood and endometrium will be analyzed for subtype percentages (CD56, CD16, CD9, CD49a), and for the expression of KIR, LILRB-1 and -2 and CD94/NKG2A receptors, that are known to interact with HLA-G and HLA-E molecules producing inhibitory signals.
- Th1, Th2, Th17 and LIF (WP3). (1-20 mth) Th1, Th2, Th17 and LIF levels will be analyzed in plasma and uterine flushing samples, to evaluate activation status. The results will be correlated with NK cell count.
- Herpesvirus infection (WP4) (12-24mth) Herpesvirus DNA (HSV-1, HSV-2, EBV, CMV, HHV-6, HHV-7, VZV and HHV-8) presence will be analyzed in peripheral blood and uterine flushing.
- HLA-G (WP5) (12-24mth) HLA-G molecules are expressed as both membrane (HLA-G1) and soluble (HLA-G5, from mRNA alternative splicing; sHLA-G1, from membrane shedding) molecules. The expression of the membrane and soluble HLA-G will be evaluated in peripheral blood and endometrium. HLA-G expression is controlled by a polymorphism of insertion/deletion (ins/del) of 14 base pairs (rs66554220), where the deletion of 14bp stabilizes the mRNA producing higher levels of HLA-G (15). We will genotype the women for rs66554220 polymorphism, to evaluate the implication in HLA-G levels of expression in infertile condition.
- HLA-E (WP6) (12-24mth) HLA-E molecules are expressed as both membrane and soluble molecules. The expression of the membrane and soluble HLA-E will be evaluated in peripheral blood and endometrium. Two non-synonymous alleles of HLA-E have been identified, HLA-ER (E*0101) and HLA-EG (E*0103) (16), where HLA-E expression of the EG protein was higher than ER. We will genotype the women for HLA-E polymorphisms, to evaluate the implication in infertility.
- Conditions
- Infertility, Female
- Being tested
- NK cell analysis, Herpesvirus detection, sHLA-G analysis, HLA-G 14bp INS/DEL typing, sHLA-E analysis
- Keywords
- Infertility, NK cells, HLA-G
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK cell analysisDiagnostic test
We selected to perform the study during the proliferative phase (day 9-11), where only resident eNK cells are present in the endometrium. The samples will be analyzed with the following methods, that are routinely used in the OUs of the proposal:
- pNK cell analysis: PBMCs will be purified with Ficoll solution and NK cells will be analyzed by flow cytometry (FacsVantage, BD) with anti-CD56, CD16, CD9, CD49a, KIRs, LILRB1, LILRB2, CD94, CD107a eNK cell analysis: eNK cells will be obtained from endometrial biopsies during proliferative phase, determined by ultrasound scan and analyzed for NK cell subtypes and KIRs, LILRB1, LILRB2, CD94, CD107a expression by flow cytometry
Herpesvirus detectionDiagnostic test
Herpesvirus detection: DNA will be analyzed by specific primers for HSV-1, HSV-2, EBV, CMV, HHV-6, HHV-7, VZV, and HHV-8, with PCR and nested PCR
sHLA-G analysisDiagnostic test
sHLA-G analysis: sHLA-G quantification in plasma and endometrial flushing will be performed by ELISA using anti-HLA-G (G233) and anti-beta2-microglobulin HRP-conjugated moAbs (Exbio)
HLA-G 14bp INS/DEL typingDiagnostic test
Genomic DNA will be genotyped by RealTime PCR
sHLA-E analysisDiagnostic test
sHLA-E analysis: sHLA-E quantification in plasma and endometrial flushing will be performed by ELISA using anti-HLA-E (3D12, eBioscience) and anti-beta2-microglobulin HRP-conjugated moAbs (Exbio)
| Study group | Role | What they receive |
|---|---|---|
| Infertile women | Inclusion criteria for the study group will be as follows: 21-38 years old, primary infertility (no live birth), regular menstrual cycle (24-35 days), body mass index (BMI) ≤ 25, FSH <10 mUI/mL, E2 < 50 pg/ml on day 2-3 of the menstrual cycle. They will be recruited at admission for tubal patency assessment. Receives: Diagnostic Test: NK cell analysis; Diagnostic Test: Herpesvirus detection; Diagnostic Test: sHLA-G analysis; Diagnostic Test: HLA-G 14bp INS/DEL typing; Diagnostic Test: sHLA-E analysis | |
| Fertile women | Inclusion criteria for control group will be as follows: 21-35 years old, almost one live birth, regular menstrual cycle (24-35 days), BMI ≤ 25, FSH <10 mUI/mL, E2 < 50 pg/mL on day 2-3 of the menstrual cycle. Women with endometritis, endometriosis, tubal factor, ovulatory dysfunction, anatomical uterine pathologies will be excluded. Receives: Diagnostic Test: NK cell analysis; Diagnostic Test: Herpesvirus detection; Diagnostic Test: sHLA-G analysis; Diagnostic Test: HLA-G 14bp INS/DEL typing; Diagnostic Test: sHLA-E analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of NK cells in female idiopathic infertility
Percentage of (e)NK CD56brightCD16-
Measured: 20 months
Herpesvirus detection
Presence of HHVs infection in endometrial cells
Measured: 16 months
Secondary outcomes (3)
Levels of sHLA-G and sHLA-E cellule pNK e eNK
Levels of sHLA-G and sHLA-E in uterine flushing samples
Measured: 16 months
HLA-G and HLA-E genetic polymorphisms
Frequency of HLA-G and HLA-E genetic polymorphisms
Measured: 10 months
Cytokines levels in endometrial flushing samples
Levels of Th1 and Th2 cytokines
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Nov 2014
- Primary completion1 Nov 2015
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- 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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Lo Monte, University Hospital of Ferrara
- Investigators
- Giuseppe Lo Monte, M.D., Principal investigator, Università di Ferarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581617
- Sponsor's protocol ID
- PRUAlGR-2013-00000084
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rizzo R, Lo Monte G, Bortolotti D, Graziano A, Gentili V, Di Luca D, Marci R. Impact of soluble HLA-G levels and endometrial NK cells in uterine flushing samples from primary and secondary unexplained infertile women. Int J Mol Sci. 2015 Mar 10;16(3):5510-6. doi: 10.3390/ijms16035510.
PubMed 25764161
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Markers in Women With Primary Unexplained Infertility
- ClinicalTrials.gov ID
- NCT03581617
- Acronym / sponsor ID
- PRUAlGR-2013-00000084
- Conditions
- Infertility, Female
- Keywords
- Infertility, NK cells, HLA-G
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 10 Jul 2018 (actual)
- 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.
- Background: In women, unexplained infertility has been associated with a range of cellular and molecular defects in the endometrium, adverse immune responses and immunological factors. Natural killer (NK) cells are included as they constitute the most abundant leukocyte population in the decidua. While decidua NK cells were extensively investigated, the study of endometrial eNK cells still lacks comprehensive researches. The reduction in eNK frequency has been associated with infertility status, in particular in the presence of a concomitant herpesvirus viremia. Since herpesviruses use as immune-escape HLA-G and HLA-E molecules, that are immune-inhibitory and important for a correct placentation, they could represent infertility co-factors.
- Aims: Since lack of an accurate diagnosis in reproductive medicine leads to treatment failure, this proposal focuses on eNK cell characterization as a diagnostic factor for unexplained women infertility. We will evaluate also co-factors, taking into consideration herpesvirus infection and HLA-G and HLA-E expression.
- Methods: Peripheral blood and endometrial NK cells will be immune-phenotyped and cell count and activation status (CD107a, IL-6, IL-10, IL-17) will be correlated with infertility condition. The implication of herpesvirus will be evaluated by DNA from peripheral blood and endometrial flushing samples analysis by HSV-1, HSV-2, EBV, CMV, HHV-6, HHV-7, VZV and HHV-8 specific primers an PCR technique. HLA-G and HLA-E expression will be analyzed in peripheral blood and endometrial environment by flow cytometry and ELISA tests and correlated by NK cell expression of their receptors (KIRs, LILRB1/2, NKG2A).
- Expected results: On the basis of our preliminary results, we expect to identify NK cells as prognostic marker for primary unexplained infertility, with herpesvirus infection and HLA-G and HLA-E expression as co-factors. These data will be of importance in the management of infertile women.
Detailed description
Primary Objective The main challenge of this project is to define the potential role of NK cells as a prognostic marker for primary unexplained infertility. To achieve this objective we will perform a prospective study on a cohort of 100 unexplained infertile women. Peripheral blood and endometrial NK cells will be immune phenotyped and their activation status will be analyzed. Meanwhile, the presence of herpesvirus infection will be evaluated in peripheral blood and correlated with the results of NK analysis. These data will clarify the role of NK cells in infertile female conditions, evaluating the implication of herpesvirus infection as a cofactor for NK cell status. These data will provide a proof of principle of the use of NK cell analysis as a predictive marker for unexplained infertility.
Secondary Objective The secondary objective is to evaluate the mechanisms at the basis of the NK cell status in infertility. Since HLA-G and HLA-E expression is modified by herpesvirus infection (9), as an immune escape mechanism, and these antigens are responsible of a correct embryo implantation (14), we will analyze the levels of these molecules in peripheral blood and endometrial environment. Meanwhile, HLA-G and HLA-E genetic polymorphisms will be analyzed. These results will be correlated with the presence of herpesvirus infection, KIR, LILRB and NKG2A receptor expression on pNK and eNK cells. These data will clarify the implication of HLA-G and HLA-E expression and genetic background in the control of NK cell activation and herpesvirus infection in infertile women.
The achievement of these objectives will be obtained with 6 workpackages/aims (WP)
- Infertile women characterization (WP1) (1-20mth) We will recruit 100 unexplained infertile women and 30 control women. These women will be clinically evaluated, establishing a clinical database. From each woman, we will obtain peripheral blood samples, endometrium biopsies, and uterine flushing.
- NK cell immune-phenotype (WP2) (1-20mth) NK cells from peripheral blood and endometrium will be analyzed for subtype percentages (CD56, CD16, CD9, CD49a), and for the expression of KIR, LILRB-1 and -2 and CD94/NKG2A receptors, that are known to interact with HLA-G and HLA-E molecules producing inhibitory signals.
- Th1, Th2, Th17 and LIF (WP3). (1-20 mth) Th1, Th2, Th17 and LIF levels will be analyzed in plasma and uterine flushing samples, to evaluate activation status. The results will be correlated with NK cell count.
- Herpesvirus infection (WP4) (12-24mth) Herpesvirus DNA (HSV-1, HSV-2, EBV, CMV, HHV-6, HHV-7, VZV and HHV-8) presence will be analyzed in peripheral blood and uterine flushing.
- HLA-G (WP5) (12-24mth) HLA-G molecules are expressed as both membrane (HLA-G1) and soluble (HLA-G5, from mRNA alternative splicing; sHLA-G1, from membrane shedding) molecules. The expression of the membrane and soluble HLA-G will be evaluated in peripheral blood and endometrium. HLA-G expression is controlled by a polymorphism of insertion/deletion (ins/del) of 14 base pairs (rs66554220), where the deletion of 14bp stabilizes the mRNA producing higher levels of HLA-G (15). We will genotype the women for rs66554220 polymorphism, to evaluate the implication in HLA-G levels of expression in infertile condition.
- HLA-E (WP6) (12-24mth) HLA-E molecules are expressed as both membrane and soluble molecules. The expression of the membrane and soluble HLA-E will be evaluated in peripheral blood and endometrium. Two non-synonymous alleles of HLA-E have been identified, HLA-ER (E*0101) and HLA-EG (E*0103) (16), where HLA-E expression of the EG protein was higher than ER. We will genotype the women for HLA-E polymorphisms, to evaluate the implication in infertility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infertile women | – | Diagnostic Test: NK cell analysis, Diagnostic Test: Herpesvirus detection, Diagnostic Test: sHLA-G analysis, Diagnostic Test: HLA-G 14bp INS/DEL typing, Diagnostic Test: sHLA-E analysisInclusion criteria for the study group will be as follows: 21-38 years old, primary infertility (no live birth), regular menstrual cycle (24-35 days), body mass index (BMI) ≤ 25, FSH <10 mUI/mL, E2 < 50 pg/ml on day 2-3 of the menstrual cycle. They will be recruited at admission for tubal patency assessment. |
| Fertile women | – | Diagnostic Test: NK cell analysis, Diagnostic Test: Herpesvirus detection, Diagnostic Test: sHLA-G analysis, Diagnostic Test: HLA-G 14bp INS/DEL typing, Diagnostic Test: sHLA-E analysisInclusion criteria for control group will be as follows: 21-35 years old, almost one live birth, regular menstrual cycle (24-35 days), BMI ≤ 25, FSH <10 mUI/mL, E2 < 50 pg/mL on day 2-3 of the menstrual cycle. Women with endometritis, endometriosis, tubal factor, ovulatory dysfunction, anatomical uterine pathologies will be excluded. |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This will be a prospective non-interventional clinical study, based on biological specimens sampled during current standard clinical practice. Based on our preliminary results, we will enroll 100 infertile and 30 control women to achieve a 0.8 power with 5% alpha error in detecting differences between infertile and fertile women.
Key inclusion criteria (10 listed)
- 21-38 years old,
- primary infertility (no live birth),
- regular menstrual cycle (24-35 days),
- body mass index (BMI) ≤ 25, FSH <10 mUI/mL,
- E2 < 50 pg/ml on day 2-3 of the menstrual cycle. Recruitment at admission for tubal patency assessment.
Key exclusion criteria (5 listed)
- endometritis,
- endometriosis,
- tubal factor,
- ovulatory dysfunction,
- anatomical uterine pathologies.
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 |
|---|---|---|
| NK cell analysisWe selected to perform the study during the proliferative phase (day 9-11), where only resident eNK cells are present in the endometrium. The samples will be analyzed with the following methods, that are routinely used in the OUs of the proposal: - pNK cell analysis: PBMCs will be purified with Ficoll solution and NK cells will be analyzed by flow cytometry (FacsVantage, BD) with anti-CD56, CD16, CD9, CD49a, KIRs, LILRB1, LILRB2, CD94, CD107a eNK cell analysis: eNK cells will be obtained from endometrial biopsies during proliferative phase, determined by ultrasound scan and analyzed for NK cell subtypes and KIRs, LILRB1, LILRB2, CD94, CD107a expression by flow cytometry | Diagnostic test | Fertile women, Infertile women |
| Herpesvirus detectionHerpesvirus detection: DNA will be analyzed by specific primers for HSV-1, HSV-2, EBV, CMV, HHV-6, HHV-7, VZV, and HHV-8, with PCR and nested PCR | Diagnostic test | Fertile women, Infertile women |
| sHLA-G analysissHLA-G analysis: sHLA-G quantification in plasma and endometrial flushing will be performed by ELISA using anti-HLA-G (G233) and anti-beta2-microglobulin HRP-conjugated moAbs (Exbio) | Diagnostic test | Fertile women, Infertile women |
| HLA-G 14bp INS/DEL typingGenomic DNA will be genotyped by RealTime PCR | Diagnostic test | Fertile women, Infertile women |
| sHLA-E analysissHLA-E analysis: sHLA-E quantification in plasma and endometrial flushing will be performed by ELISA using anti-HLA-E (3D12, eBioscience) and anti-beta2-microglobulin HRP-conjugated moAbs (Exbio) | Diagnostic test | Fertile women, Infertile women |
Primary outcome
Prognostic value of NK cells in female idiopathic infertility
Time frame: 20 months
Percentage of (e)NK CD56brightCD16-
Herpesvirus detection
Time frame: 16 months
Presence of HHVs infection in endometrial cells
3 secondary outcomes
Levels of sHLA-G and sHLA-E cellule pNK e eNK
Time frame: 16 months
HLA-G and HLA-E genetic polymorphisms
Time frame: 10 months
Cytokines levels in endometrial flushing samples
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Background: PubMed 25764161Rizzo R, Lo Monte G, Bortolotti D, Graziano A, Gentili V, Di Luca D, Marci R. Impact of soluble HLA-G levels and endometrial NK cells in uterine flushing samples from primary and secondary unexplained infertile women. Int J Mol Sci. 2015 Mar 10;16(3):5510-6. doi: 10.3390/ijms16035510.
- 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.
Giuseppe Lo Monte, M.D. principal investigator
Università di Ferarra
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by University Hospital of Ferrara.
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 10 inclusion and 5 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: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value of NK cells in female idiopathic infertility (time frame: 20 months). 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 NCT03581617, which also lists 1 linked publication.
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 10 Jul 2018.