US 12,293,838 B2
System for the ovarian reserve function assessment of subjects
Rong Li, Beijing (CN); Huiyu Xu, Beijing (CN); and Jie Qiao, Beijing (CN)
Assigned to GUANGZHOU KANGRUN BIOTECH CO., LTD, Guangdong (CN)
Appl. No. 17/413,182
Filed by GUANGZHOU KANGRUN BIOTECH CO., LTD, Guangdong (CN)
PCT Filed Dec. 28, 2018, PCT No. PCT/CN2018/124766
§ 371(c)(1), (2) Date Jun. 11, 2021,
PCT Pub. No. WO2020/118790, PCT Pub. Date Jun. 18, 2020.
Claims priority of application No. 201811516206.4 (CN), filed on Dec. 12, 2018.
Prior Publication US 2022/0044822 A1, Feb. 10, 2022
Int. Cl. G16H 50/30 (2018.01); A61B 5/00 (2006.01); G01N 33/68 (2006.01); G01N 33/76 (2006.01); G06F 17/18 (2006.01)
CPC G16H 50/30 (2018.01) [A61B 5/4325 (2013.01); G01N 33/689 (2013.01); G01N 33/76 (2013.01); G06F 17/18 (2013.01)] 5 Claims
OG exemplary drawing
 
1. A method for assessing an ovarian reserve function of a subject, comprising:
(A) a data acquisition step, in which the data of an age, anti-Müllerian hormone (AMH) level, follicle stimulating hormone (FSH) level, and antral follicle count (AFC) of the subject are acquired;
(B) an ovarian reserve function calculation step, in which the data of the age, the anti-Müllerian hormone (AMH) level, the follicle stimulating hormone (FSH) level, and the antral follicle count (AFC) acquired in the data acquisition step is used to calculate a probability of poor ovarian response (p) of the subject, wherein in the ovarian reserve function calculation step, a receiver operating characteristic (ROC) curve is used to detect cutoff points of the age, the anti-Müllerian hormone (AMH) level, the follicle stimulating hormone (FSH) level, and the antral follicle count (AFC), and according to tangent point values of the cutoff points, the age, the anti-Müllerian hormone (AMH) level, the follicle stimulating hormone (FSH) level, and the antral follicle count (AFC) are transformed into dichotomous variables, thereby the dichotomous variables are used to calculate the subject's probability of poor ovarian response (p) based on the following formula (1),

OG Complex Work Unit Math
wherein,
p is a calculated parameter used to characterize the ovarian reserve function of the subject,
i is any numeric value selected from −1.786 to −0.499,
a is any numeric value selected from 0.063 to 1.342,
b is any numeric value selected from −2.542 to −1.056,
c is any numeric value selected from 0.548 to 1.838, and
d is any numeric value selected from −2.133 to −0.51;
(C) grouping the subject based on the p value, wherein
(i) when p is <5%, the ovarian reserve function of the subject is good;
(ii) when 5% ≤p<20%, the ovarian reserve function of the subject starts to decline;
(iii) when 20%≤p<50%, the ovarian reserve function of the subject declines significantly; and
(iv) when p is ≥50%, the ovarian reserve function of the subject is poor; and
(D) an administering step of administering a starting dosage of an exogenous ovulation stimulant (Gn) to the subject, wherein the starting dosage is determined based on the p value and the grouping as defined in FIG. 6, wherein:
when p is <5%, the starting dosage of Gn is 75 to 375 IU;
when 5% ≤p<20%, the starting dosage of Gn is 115 to 450 IU;
when 20% ≤p<50%, the starting dosage of Gn is 150 to 450 IU; and
when p is ≥50%, the starting dosage of Gn is 150 to 450 IU.