Infertility, Female Clinical Trial
Official title:
Prognostic Markers in Women With Primary Unexplained Infertility
Verified date | June 2018 |
Source | University Hospital of Ferrara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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. 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.
2. 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.
3. 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).
4. 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.
Status | Completed |
Enrollment | 143 |
Est. completion date | November 1, 2016 |
Est. primary completion date | November 1, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 38 Years |
Eligibility |
Inclusion criteria for the study group : - 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. Inclusion criteria for control group: - 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 Exclusion criteria: - endometritis, - endometriosis, - tubal factor, - ovulatory dysfunction, - anatomical uterine pathologies. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Ferrara |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prognostic value of NK cells in female idiopathic infertility | Percentage of (e)NK CD56brightCD16- | 20 months | |
Primary | Herpesvirus detection | Presence of HHVs infection in endometrial cells | 16 months | |
Secondary | Levels of sHLA-G and sHLA-E cellule pNK e eNK | Levels of sHLA-G and sHLA-E in uterine flushing samples | 16 months | |
Secondary | HLA-G and HLA-E genetic polymorphisms | Frequency of HLA-G and HLA-E genetic polymorphisms | 10 months | |
Secondary | Cytokines levels in endometrial flushing samples | Levels of Th1 and Th2 cytokines | 10 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05969574 -
Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
|
||
Recruiting |
NCT05358483 -
PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
|
||
Recruiting |
NCT05969795 -
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
|
Phase 1 | |
Recruiting |
NCT06051201 -
Innovation for Small-scale Experiments: ReceptIVFity Test
|
N/A | |
Completed |
NCT03177538 -
Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders
|
Phase 4 | |
Completed |
NCT03638856 -
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy
|
N/A | |
Completed |
NCT04052464 -
The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
|
||
Withdrawn |
NCT04753736 -
Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC
|
N/A | |
Completed |
NCT03349905 -
Deferred Versus Fresh Embryo Transfers
|
N/A | |
Completed |
NCT05076981 -
Progesterone Levels During Ovulation and Luteal Phase
|
||
Completed |
NCT04096027 -
Cabergoline Before or After Oocyte Collection for Follicular Resolution
|
Phase 4 | |
Recruiting |
NCT05980091 -
Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.
|
Phase 1 | |
Terminated |
NCT01933633 -
Improved Fertility After Exercise in Overweight/Obese Women
|
N/A | |
Completed |
NCT01202656 -
Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)
|
Phase 1/Phase 2 | |
Terminated |
NCT01202643 -
Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF
|
Phase 1/Phase 2 | |
Completed |
NCT01408615 -
A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
|
||
Enrolling by invitation |
NCT05698550 -
The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET
|
Phase 3 | |
Not yet recruiting |
NCT03910582 -
Personalized FET in RIF Patients With Displaced Dating
|
N/A | |
Completed |
NCT05440019 -
Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
|
||
Completed |
NCT05130125 -
Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer
|