Claims for Patent: 10,509,043

Summary for Patent: 10,509,043

Title:	Methods for identification of pregnancy failure
Abstract:	Provided is a method for identifying pregnancy failure in a subject, the method comprising determining a concentration of at least one element of fetal or embryonic origin in the vaginal fluid of the subject; and comparing the concentration of the at least one element of fetal or embryonic origin to a reference value, wherein when the concentration of the at least one element of fetal or embryonic origin in the vaginal fluid is higher than the reference value, pregnancy failure is indicated.
Inventor(s):	Mor; Amir (New Haven, CT)
Assignee:	Mor; Amir (New haven, CT)
Application Number:	15/951,187
Patent Claims:	1. A method for treating a subject suspected of pregnancy failure, the method comprising: determining a concentration of alpha fetoprotein in the vaginal fluid of the subject; and comparing said concentration of said alpha fetoprotein to a reference value, wherein when said concentration of said alpha fetoprotein in said vaginal fluid is higher than said reference value, pregnancy failure is indicated, and treating the subject in whom pregnancy failure is indicated by administration of uterotonics and/or a dilation and curettage procedure. 2. The method of claim 1, wherein said reference value is a concentration of said alpha fetoprotein in maternal serum of the same subject. 3. The method of claim 1, wherein said vaginal fluid is vaginal blood. 4. The method of claim 1, wherein the pregnancy failure is a failure of an intrauterine pregnancy. 5. The method of claim 4, wherein said reference value is a concentration of said alpha fetoprotein in maternal serum of the same subject, and wherein pregnancy failure is indicated when a ratio of a concentration of said alpha fetoprotein in said vaginal fluid to concentration of said alpha fetoprotein in said maternal serum is higher than a predetermined threshold ratio level. 6. The method of claim 5, wherein said predetermined threshold ratio level is 13.4. 7. The method of claim 4, wherein said reference value is a predetermined concentration value of said alpha fetoprotein, and wherein pregnancy failure is indicated when a concentration of said alpha fetoprotein in said vaginal fluid of the subject is higher than the predetermined concentration value. 8. The method of claim 7, wherein said predetermined reference value is 9.2 ng/mL. 9. The method of claim 1, wherein the pregnancy failure is a spontaneous abortion or an induced abortion. 10. The method of claim 9, wherein the pregnancy failure is selected from the group consisting of a complete abortion, an incomplete abortion and a missed abortion. 11. The method of claim 1, wherein the pregnancy failure is a failure of a first or second trimester pregnancy. 12. The method of claim 1, wherein said pregnancy failure is selected from the group consisting of an ectopic pregnancy, a molar pregnancy, a blighted ovum, and an anembryonic pregnancy the method further comprising determining a concentration of a known hormonal marker of pregnancy in the blood or urine of the subject and identifying the absence of alpha fetoprotein, wherein said reference value is a concentration of said alpha fetoprotein in maternal serum of the same subject, and wherein ectopic pregnancy is indicated by i) a ratio of a concentration of said alpha fetoprotein in said vaginal fluid to concentration of said alpha fetoprotein in said maternal serum of about 4.3 or less, ii) absence of sonographic evidence of an intrauterine fetal or embryonic tissue; and iii) a concentration of said hormonal marker of pregnancy in the blood or urine of the subject of at least 1 mIU/mL. 13. The method of claim 12, wherein said hormonal marker of pregnancy comprises beta Human Chorionic gonadotropin (.beta.-HCG).

Details for Patent 10,509,043

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	January 15, 1974	10,509,043	2038-04-12
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	December 27, 1984	10,509,043	2038-04-12
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 15, 1985	10,509,043	2038-04-12
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 16, 1990	10,509,043	2038-04-12
Bel-mar Laboratories, Inc.	CHORIONIC GONADOTROPIN	chorionic gonadotropin	Injection	017054	March 26, 1974	10,509,043	2038-04-12
Fresenius Kabi Usa, Llc	CHORIONIC GONADOTROPIN	chorionic gonadotropin	For Injection	017067	March 05, 1973	10,509,043	2038-04-12