Infertility Clinical Trial
— Ca2+Official title:
To Investigate How Secreted-embryo-derived Trypsin Initiates, Maintains and Terminates Ca2+ (Intracellular Calcium) Signals in Uterine Epithelial Cells
Verified date | July 2023 |
Source | ART Fertility Clinics LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To develop a deeper understanding of endometrial-embryo crosstalk through basic research, uncover therapeutic targets and to improve reproductive outcome.
Status | Active, not recruiting |
Enrollment | 81 |
Est. completion date | January 15, 2024 |
Est. primary completion date | November 16, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility | Inclusion Criteria: - Couples with primary / secondary infertility who are planned to undergo ICSI treatment with PGT-A - Age of each partner above 18 years Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | ART Fertility Clinics LLC | Abu Dhabi |
Lead Sponsor | Collaborator |
---|---|
ART Fertility Clinics LLC | University Women's Hospital Tübingen |
United Arab Emirates,
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Marunaka 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. — View Citation
Mertzanidou 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. — View Citation
Quenby 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. — View Citation
Rossier 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. — View Citation
Ruan 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. — View Citation
Salker 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. — View Citation
Singh 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. — View Citation
Teklenburg 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. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Change in peak and slope levels of intracellular calcium | Change in peak and slope levels of intracellular calcium | 1 day | |
Primary | Change in morphohology of cells after incubation with embryo media | Change in morphohology of cells after incubation with embryo media | 1 day | |
Secondary | Performance of ICSI | Defined on day 0 as the number of injected oocytes/number of COCs assigned to the ICSI group | 1 day | |
Secondary | Embryo quality on day 3 | Defined by the number of blastomeres and their division pattern, fragmentation, presence of compaction, vacuoles, granulation and nuclei | 1 day | |
Secondary | Embryo quality on day 5 (Gardner and Schoolcraft,1999) | Gardner and Schoolcraft,1999) defined by:
The expansion stage of the blastocyst Quality of the ICM and TE Day on which the biopsy is performed (day 5,6 or 7) Pregnancy outcomes (miscarriages/ectopic pregnancy/neonatal outcome) |
1 day |
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