Recurrent Implantation Failure Clinical Trial
— PIPOfficial title:
The PIP Study- Pre- IVF Immune Profiling Study
NCT number | NCT03660735 |
Other study ID # | 13399 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 26, 2018 |
Est. completion date | August 1, 2021 |
Many IVF clinics offer testing for immune cells in the blood and endometrium as it has been suggested that abnormal levels of these cells can affect fertility or the chance of an IVF cycle working. However, routinely offering these tests remains highly controversial as the scientific evidence behind the tests is not of a high quality. The PIP Study aims to find out how a woman's blood and endometrial immune cells affect the likelihood of an IVF cycle working and whether or not they are different in women with subfertility and implantation failure. This feasibility study aims to find out if it is possible to enrol enough women into the research study. If this is successful, the investigators will then go on to recruit a larger group of women into the main PIP study to enable them to investigate the impact of immune profiling on IVF success in more detail.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | August 1, 2021 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
Inclusion Criteria: - Participant is willing and able to give informed consent for participation in the study. - Female, aged 18 years to 39 years at the time of egg collection. - Participant has an ovulatory cycle of 25-35 days. - Participant is undergoing: - A first or second cycle of IVF and ICSI for male factor subfertility, or - An IVF cycle to treat subfertility with a history of RIF, or - An IVF cycle to treat at least 1 year of subfertility We do not plan to target specific numbers in each group. Rather, the numbers that recruit in each group will be assessed at the end of the study and may well influence the design of the main study. Exclusion Criteria: The participant may not enter the study if ANY of the following apply: - Donor egg cycle. - Age 40 or above at the time of egg collection. - Ovulatory cycle of <25 or >35 days or evidence of anovulation - Involved in a interventional research study of any medication that may have an effect on the immune system - Patient taking oral steroids or other immunomodulatory medication |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Wolfson Fertility Centre | London | |
United Kingdom | IVI Oxford | Oxford |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Finox Biotech |
United Kingdom,
Beer AE, Kwak JY, Ruiz JE. Immunophenotypic profiles of peripheral blood lymphocytes in women with recurrent pregnancy losses and in infertile women with multiple failed in vitro fertilization cycles. Am J Reprod Immunol. 1996 Apr;35(4):376-82. — View Citation
Kwak-Kim JY, Chung-Bang HS, Ng SC, Ntrivalas EI, Mangubat CP, Beaman KD, Beer AE, Gilman-Sachs A. Increased T helper 1 cytokine responses by circulating T cells are present in women with recurrent pregnancy losses and in infertile women with multiple implantation failures after IVF. Hum Reprod. 2003 Apr;18(4):767-73. — View Citation
McGrath E, Ryan EJ, Lynch L, Golden-Mason L, Mooney E, Eogan M, O'Herlihy C, O'Farrelly C. Changes in endometrial natural killer cell expression of CD94, CD158a and CD158b are associated with infertility. Am J Reprod Immunol. 2009 Apr;61(4):265-76. doi: 10.1111/j.1600-0897.2009.00688.x. — View Citation
Moffett A, Regan L, Braude P. Natural killer cells, miscarriage, and infertility. BMJ. 2004 Nov 27;329(7477):1283-5. Review. — View Citation
Nastri CO, Lensen SF, Gibreel A, Raine-Fenning N, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2015 Mar 22;(3):CD009517. doi: 10.1002/14651858.CD009517.pub3. Review. — View Citation
Ng SC, Gilman-Sachs A, Thaker P, Beaman KD, Beer AE, Kwak-Kim J. Expression of intracellular Th1 and Th2 cytokines in women with recurrent spontaneous abortion, implantation failures after IVF/ET or normal pregnancy. Am J Reprod Immunol. 2002 Aug;48(2):77-86. — View Citation
Polanski LT, Baumgarten MN, Quenby S, Brosens J, Campbell BK, Raine-Fenning NJ. What exactly do we mean by 'recurrent implantation failure'? A systematic review and opinion. Reprod Biomed Online. 2014 Apr;28(4):409-23. doi: 10.1016/j.rbmo.2013.12.006. Epub 2014 Jan 17. Review. — View Citation
Rai R, Sacks G, Trew G. Natural killer cells and reproductive failure--theory, practice and prejudice. Hum Reprod. 2005 May;20(5):1123-6. Epub 2005 Mar 10. Review. — View Citation
Seshadri S, Sunkara SK. Natural killer cells in female infertility and recurrent miscarriage: a systematic review and meta-analysis. Hum Reprod Update. 2014 May-Jun;20(3):429-38. doi: 10.1093/humupd/dmt056. Epub 2013 Nov 27. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Identify novel differences in the endometrial cellular landscape and cell function in women with recurrent implantation failure and subfertility | Comparative studies of endometrial cell phenotype and function, including CyTOF, development in culture, mRNA expression, cytokine levels and response to exogenous factors in control / RIF and subfertility populations | Blood and endometrial biopsies will be analysed throughout the study (a period of 36 months) but comparison between groups will take place after 3 years, at study completion | |
Primary | Recruitment of 250 participants to subgroups relevant to a future larger study | Recruitment rate of participants screened eligible for the study of recruits who are undoing a first or second IVF cycle with ICSI for male factor subfertility of recruits with a history of recurrent implantation failure |
At study completion, this is anticipated to be 3 years. | |
Secondary | To describe the normal variation in blood and endometrial immune cell populations in the mid-luteal phase of the menstrual cycle of women in undergoing IVF for a severe male factor subfertility who go on to have a live birth | Descriptive data to define the populations of blood and endometrial cells, this will include NK and T cells as well as smaller immune cell populations. | Blood and endometrial biopsies will be analysed throughout the study (a period of 36 months) but comparison between groups will take place after 3 years, at study completion | |
Secondary | To identify if there are significant differences in endometrial or blood immune cell populations in: Women with a history of Recurrent Implantation Failure Women with a history of subfertility | Significant differences in cellular parameters between control group and RIF / subfertility | Blood and endometrial biopsies will be analysed throughout the study (a period of 36 months) but comparison between groups will take place after 3 years, at study completion | |
Secondary | To identify if there are differences in immune cell parameters between successful and failed cycles | Differences in immune cell parameters depending on pregnancy outcome | Blood and endometrial biopsies will be analysed throughout the study (a period of 36 months) but comparison between groups will take place after 3 years, at study completion | |
Secondary | To identify if there is a relationship between endometrial and peripheral blood immune cell parameters | Correlation between endometrial and blood immune cell parameters | Blood and endometrial biopsies will be analysed throughout the study (a period of 36 months) but comparison between groups will take place after 3 years, at study completion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04528277 -
Short Course Rifapentine and Isoniazid for the Preventive Treatment for Latent Genital Tuberculosis
|
Phase 3 | |
Recruiting |
NCT04998279 -
Intrauterine Infusion of GCSF and Reproductive Outcomes in Infertile Women With History of RIF
|
||
Completed |
NCT03267797 -
hCG-activated PBMC-therapy in RIF Patients
|
N/A | |
Recruiting |
NCT04118959 -
Role of Atosiban in Recurrent Implantation Failure
|
||
Recruiting |
NCT05343572 -
Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
|
Early Phase 1 | |
Not yet recruiting |
NCT02752568 -
Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure
|
N/A | |
Recruiting |
NCT04822207 -
Effect of Acupuncture on the Clinical Outcome of IVF-ET in Patients With Recurrent Implantation Failure
|
N/A | |
Recruiting |
NCT03900780 -
Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure
|
N/A | |
Not yet recruiting |
NCT03549728 -
Effect of Granulocyte Colony-stimulating Factor on Clinical Pregnancy Rate in Patients With Endometriosis
|
Phase 2 | |
Completed |
NCT03174964 -
Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Implantation Failure
|
Phase 2 | |
Completed |
NCT03161340 -
Immunomodulatory Effects of Rapamycin on Pregnancy Rate of Patient With Recurrent Implantation Failure
|
Phase 2 | |
Not yet recruiting |
NCT01278706 -
Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)
|
N/A | |
Completed |
NCT00750451 -
Low Molecular Weight Heparin in Recurrent Implantation Failure
|
N/A | |
Not yet recruiting |
NCT03690830 -
Use of Metabolomics for the Identification of Endometrial Biomarkers for IRPL and RIF After in Vitro Fertilization
|
N/A | |
Not yet recruiting |
NCT03355937 -
Using Microfluidic Separation Sperm Selection for Unexplained Infertility and Reccurrent Implantation Failure
|
N/A | |
Recruiting |
NCT05169541 -
Association Between Plasma Level of Mannose Binding Lectin and Human Reproduction
|
||
Completed |
NCT04085783 -
PRP in Recurrent Implantation Failure
|
N/A | |
Not yet recruiting |
NCT03365466 -
Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women
|
N/A | |
Active, not recruiting |
NCT03421639 -
Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis
|
Phase 4 | |
Recruiting |
NCT04293068 -
Effect of Reproductive Tract Microbiota on Pregnancy Outcome in IVF/ICSI
|