How Secreted-embryo-derived Trypsin Initiates, Maintains and Terminates Ca2+ Signals in Uterine Epithelial Cells
Ca2+
To Investigate How Secreted-embryo-derived Trypsin Initiates, Maintains and Terminates Ca2+ (Intracellular Calcium) Signals in Uterine Epithelial Cells
1 other identifier
observational
81
1 country
1
Brief Summary
To develop a deeper understanding of endometrial-embryo crosstalk through basic research, uncover therapeutic targets and to improve reproductive outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
April 29, 2021
CompletedStudy Start
First participant enrolled
November 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2023
CompletedJuly 17, 2024
July 1, 2024
1.4 years
April 26, 2021
July 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in markers of protein
Change in markers of protein (PAR2, (p) and SGK1, NFkB, ORAI1-3 and STIM1-2 and COX2) using Western blotting
1 day
Change in peak and slope levels of intracellular calcium
Change in peak and slope levels of intracellular calcium
1 day
Change in morphohology of cells after incubation with embryo media
Change in morphohology of cells after incubation with embryo media
1 day
Secondary Outcomes (3)
Performance of ICSI
1 day
Embryo quality on day 3
1 day
Embryo quality on day 5 (Gardner and Schoolcraft,1999)
1 day
Study Arms (4)
DEG n1: euploid medium
culture media derived from euploid embryos
DEG n2: aneuploid medium
culture media derived from aneuploid embryos
DEG n3: medium arrested embryos
culture media derived from arrested embryos
DEG n4: control culture medium
pure culture media without contact to embryos
Interventions
Exposure to culture media
Eligibility Criteria
Arab ethnicity, with primary / secondary infertility, who undergo an ICSI treatment with preimplantation genetic testing for aneuploidies.
You may qualify if:
- Couples with primary / secondary infertility who are planned to undergo ICSI treatment with PGT-A
- Age of each partner above 18 years
You may not qualify if:
- Couples with consanguinity (couple who is 1st or 2nd degree cousins)
- Couples in whom the female partner has a history of:
- Chemotherapy or radiation which impacts the ovarian reserve
- Surgery at the ovaries / adnex region
- Endometriosis
- Couples in whom the male partner has a history of:
- Chemotherapy / Radiation which impacts the semen result
- Surgery at the testicles
- Vasectomy
- Surgery for reversal of vasectomy
- Semen obtained by fine needle aspiration (FNA) or Testicular sperm extraction (TESE)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ART Fertility Clinics LLClead
- University Women's Hospital Tübingencollaborator
Study Sites (1)
ART Fertility Clinics LLC
Abu Dhabi, 60202, United Arab Emirates
Related Publications (15)
Wang H, Dey SK. Roadmap to embryo implantation: clues from mouse models. Nat Rev Genet. 2006 Mar;7(3):185-99. doi: 10.1038/nrg1808.
PMID: 16485018BACKGROUNDKaneko Y, Day ML, Murphy CR. Integrin beta3 in rat blastocysts and epithelial cells is essential for implantation in vitro: studies with Ishikawa cells and small interfering RNA transfection. Hum Reprod. 2011 Jul;26(7):1665-74. doi: 10.1093/humrep/der128. Epub 2011 Apr 30.
PMID: 21531996BACKGROUNDMertzanidou A, Wilton L, Cheng J, Spits C, Vanneste E, Moreau Y, Vermeesch JR, Sermon K. Microarray analysis reveals abnormal chromosomal complements in over 70% of 14 normally developing human embryos. Hum Reprod. 2013 Jan;28(1):256-64. doi: 10.1093/humrep/des362. Epub 2012 Oct 9.
PMID: 23054067BACKGROUNDTeklenburg G, Salker M, Heijnen C, Macklon NS, Brosens JJ. The molecular basis of recurrent pregnancy loss: impaired natural embryo selection. Mol Hum Reprod. 2010 Dec;16(12):886-95. doi: 10.1093/molehr/gaq079. Epub 2010 Sep 16.
PMID: 20847090BACKGROUNDQuenby S, Vince G, Farquharson R, Aplin J. Recurrent miscarriage: a defect in nature's quality control? Hum Reprod. 2002 Aug;17(8):1959-63. doi: 10.1093/humrep/17.8.1959.
PMID: 12151421BACKGROUNDAplin JD. Embryo implantation: the molecular mechanism remains elusive. Reprod Biomed Online. 2006 Dec;13(6):833-9. doi: 10.1016/s1472-6483(10)61032-2.
PMID: 17169205BACKGROUNDZhang S, Lin H, Kong S, Wang S, Wang H, Wang H, Armant DR. Physiological and molecular determinants of embryo implantation. Mol Aspects Med. 2013 Oct;34(5):939-80. doi: 10.1016/j.mam.2012.12.011. Epub 2013 Jan 2.
PMID: 23290997BACKGROUNDRuan YC, Guo JH, Liu X, Zhang R, Tsang LL, Dong JD, Chen H, Yu MK, Jiang X, Zhang XH, Fok KL, Chung YW, Huang H, Zhou WL, Chan HC. Activation of the epithelial Na+ channel triggers prostaglandin E(2) release and production required for embryo implantation. Nat Med. 2012 Jul;18(7):1112-7. doi: 10.1038/nm.2771.
PMID: 22729284BACKGROUNDRossier BC, Stutts MJ. Activation of the epithelial sodium channel (ENaC) by serine proteases. Annu Rev Physiol. 2009;71:361-79. doi: 10.1146/annurev.physiol.010908.163108.
PMID: 18928407BACKGROUNDMarunaka Y, Niisato N. Effects of Ca(2+) channel blockers on amiloride-sensitive Na(+) permeable channels and Na(+) transport in fetal rat alveolar type II epithelium. Biochem Pharmacol. 2002 Apr 15;63(8):1547-52. doi: 10.1016/s0006-2952(02)00880-8.
PMID: 11996897BACKGROUNDSalker MS, Hosseinzadeh Z, Alowayed N, Zeng N, Umbach AT, Webster Z, Singh Y, Brosens JJ, Lang F. LEFTYA Activates the Epithelial Na+ Channel (ENaC) in Endometrial Cells via Serum and Glucocorticoid Inducible Kinase SGK1. Cell Physiol Biochem. 2016;39(4):1295-306. doi: 10.1159/000447834. Epub 2016 Sep 8.
PMID: 27606670BACKGROUNDSingh Y, Shi X, Zhang S, Umbach AT, Chen H, Salker MS, Lang F. Prolyl hydroxylase 3 (PHD3) expression augments the development of regulatory T cells. Mol Immunol. 2016 Aug;76:7-12. doi: 10.1016/j.molimm.2016.06.003. Epub 2016 Jun 19.
PMID: 27331863BACKGROUNDHeijnen EM, Eijkemans MJ, De Klerk C, Polinder S, Beckers NG, Klinkert ER, Broekmans FJ, Passchier J, Te Velde ER, Macklon NS, Fauser BC. A mild treatment strategy for in-vitro fertilisation: a randomised non-inferiority trial. Lancet. 2007 Mar 3;369(9563):743-749. doi: 10.1016/S0140-6736(07)60360-2.
PMID: 17336650BACKGROUNDBrosens JJ, Salker MS, Teklenburg G, Nautiyal J, Salter S, Lucas ES, Steel JH, Christian M, Chan YW, Boomsma CM, Moore JD, Hartshorne GM, Sucurovic S, Mulac-Jericevic B, Heijnen CJ, Quenby S, Koerkamp MJ, Holstege FC, Shmygol A, Macklon NS. Uterine selection of human embryos at implantation. Sci Rep. 2014 Feb 6;4:3894. doi: 10.1038/srep03894.
PMID: 24503642BACKGROUNDTurco MY, Gardner L, Hughes J, Cindrova-Davies T, Gomez MJ, Farrell L, Hollinshead M, Marsh SGE, Brosens JJ, Critchley HO, Simons BD, Hemberger M, Koo BK, Moffett A, Burton GJ. Long-term, hormone-responsive organoid cultures of human endometrium in a chemically defined medium. Nat Cell Biol. 2017 May;19(5):568-577. doi: 10.1038/ncb3516. Epub 2017 Apr 10.
PMID: 28394884BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BARBARA LAWRENZ, PhD
ART Fertility Clinics LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientific Director
Study Record Dates
First Submitted
April 26, 2021
First Posted
April 29, 2021
Study Start
November 4, 2021
Primary Completion
April 16, 2023
Study Completion
May 15, 2023
Last Updated
July 17, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share