Carrier status of annexin A5 M2 haplotype and obstetric risks
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Assignees
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Publication Number
US-10925891-B2
Publication Date
2021-02-23
Expiration Date
Abstract
The present invention relates to determining the carrier status of Annexin A5 M2 haplotype of parents (both male and female) prior to and/or after pregnancy to minimize the risk of pregnancy complications, including, but not limited to, recurrent pregnancy loss (RPL), infertility, miscarriage, in vitro fertilization (IVF) failure, IUI failure, implantation failure, foetal growth restriction (FGR), small for gestational age (SGA) newborn, intra-uterine foetal death (IUFD), gestational hypertension (GH), pre-eclampsia (PE) and/or venous thromboembolism (VTE). Once M2 carrier status is determined, methods of intervention, including administration of low molecular weight heparin (LMWH) and/or other anti-coagulants can be administered either prior to and/or after pregnancy. Methods of detecting the carrier status as well as method of diagnosing and or predicting prognosis based on the M2 carrier status of a patient and/or couple is also contemplated.
Core Innovation
The disclosed subject matter relates to detecting or having detected a carrier status for an ANXA5 M2 haplotype in a biological mother and/or a biological father, and to treating an ANXA5 M2 haplotype pregnancy based on that status. An ANXA5 M2 haplotype pregnancy is defined as a pregnancy existing when either the biological mother and/or the biological father is a carrier of the ANXA5 M2 haplotype, with the additional condition that both mother and father have undergone genetic testing to determine their individual M2 haplotype status.
The problem addressed is pregnancy complications associated with an ANXA5 M2 haplotype pregnancy, including recurrent pregnancy loss (RPL), IVF/IUI failure, implantation failure, foetal growth restriction (FGR) / small for gestational age (SGA), intra-uterine foetal death (IUFD), gestational hypertension (GH) / pre-eclampsia (PE), and venous thromboembolism (VTE). The document characterizes the ANXA5 M2 haplotype as affecting placental/embryonic anticoagulation mechanisms.
The treatment concept comprises administering an effective amount of an anticoagulant to the mother at a selected time, including within 14 days prior to pregnancy, at the time of implantation, and/or at the time of embryo transfer in in vitro fertilization. The document further describes genomic detection approaches for identifying the ANXA5 M2 haplotype carrier status, including PCR/sequencing/SNP detection and a genotyping approach referred to as IHG Pharmaco, as well as oligo-based and next-generation sequencing options.
Claims Coverage
The partial content includes one independent claim directed to treating a M2 haplotype pregnancy using genetic testing of mother and father followed by anticoagulant administration at selected time points. Dependent claims refine the inventive features by specifying the anticoagulant choice, administration timing/duration, carrier eligibility criteria, and genetic detection approaches.
Treating a M2 haplotype pregnancy based on mother and father carrier testing
A method of treating a M2 haplotype pregnancy by detecting (or having detected) that the M2 haplotype pregnancy exists when either the biological mother and/or the biological father is a carrier of the ANXA5 M2 haplotype, wherein both mother and father have undergone genetic testing to determine their individual M2 haplotype status, and wherein the mother suffers from recurrent pregnancy loss (RPL)
Administering an anticoagulant at selected times for the detected M2 haplotype pregnancy
Administering to the mother of the M2 haplotype pregnancy an effective amount of an anticoagulant at a time selected from within 14 days prior to pregnancy, at the time of implantation, and at the time of embryo transfer in in vitro fertilization
Using LMWH as the anticoagulant
The method further includes administering low molecular weight heparin (LMWH) as the anticoagulant
Daily anticoagulant administration through pregnancy and/or after delivery
The method further includes administering an anticoagulant every day throughout pregnancy until before delivery and/or for an additional 6 weeks after delivery
Requiring that both parents are carriers of the ANXA5 M2 haplotype
The method is performed where both the biological mother and biological father carry the ANXA5 M2 haplotype
Determining ANXA5 M2 carrier status using PCR, sequencing, or IHG Pharmaco SNP detection
Determining the ANXA5 M2 carrier status of a mother or father using polymerase chain reaction (PCR), sequencing techniques, or the single nucleotide polymorphism detection technique established by IHG Pharmaco
Overall, the claim coverage centers on treating an ANXA5 M2 haplotype pregnancy by first establishing ANXA5 M2 haplotype carrier status via genetic testing of both parents, followed by administering an effective amount of an anticoagulant to the mother at selected peri-pregnancy, implantation, or embryo-transfer time points. Dependent claims further narrow anticoagulant selection to LMWH, refine administration timing and duration, and specify genetic testing modalities including PCR, sequencing, and IHG Pharmaco-based SNP detection.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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