# US 8,541,245 B2 · Method for assessing oocyte maturation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,541,245 B2 - Document ID: US8541245B2 - Status: Granted - Kind: B2 - Application number: 12/814,038 - Filed: 2010-06-11 - Published: 2011-05-12 - Granted: 2013-09-24 - Earliest claimed: 2009-06-12 - Assignees: Beckman Coulter, Inc. - Applicants: William E. Roudebush - Inventors: William E. Roudebush - Web page: https://patentgrep.com/patent/US8541245B2 ## CPC - G01N 33/689: {related to pregnancy or the gonads} - G01N 2333/471: Pregnancy proteins, e.g. placenta proteins, alpha-feto-protein, pregnancy specific beta glycoprotein - G01N 2800/367: Infertility, e.g. sperm disorder, ovulatory dysfunction - Y10T 436/10: Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing - Y10T 436/105831: Protein or peptide standard or control [e.g., hemoglobin, etc.] - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract The present invention provides methods and kits for assessing the state of oocyte maturation in a female mammal based on the level of PAPP-A found in the female's bodily fluid sample. ## Claims ### Claim 1 A method for assessing oocyte maturation in a female, comprising detecting pregnancy-associated plasma protein (PAPP-A) level in a bodily fluid from the female, wherein the PAPP-A level of the female is detected daily for a least three consecutive days; comparing the PAPP-A level with a control to assess oocyte maturation in the female, the control comprising a previously established baseline PAPP-A level for the bodily fluid of the same female or an average PAPP-A level for the bodily fluid from a healthy fertile non-pregnant female, wherein an increase in the PAPP-A level compared to the control indicates a more advanced state of oocyte maturation and a decrease in the PAPP-A level compared to the control indicates a lesser state of oocyte maturation; and administering a hormone which induces oocyte maturation to the female within 36 hours after the PAPP-A level in the female exhibits a decrease after continuous increase for at least two consecutive days, the hormone being administered to the female in an amount sufficient to induce final maturation of oocytes in the female. ### Claim 2 (depends on 1) The method of claim 1, wherein the PAPP-A level is the PAPP-A protein level of total PAPP-A, PAPP-A homodimer, or PAPP-A/proform of eosinophil major basic protein (proMBP) heterodimer. ### Claim 3 (depends on 1) The method of claim 1, wherein the bodily fluid is follicular fluid, serum or plasma. ### Claim 4 (depends on 1) The method of claim 1, wherein the control is the average PAPP-A level for the body fluid from a healthy fertile non-pregnant female. ### Claim 5 (depends on 1) The method of claim 1, wherein the control is a previously established baseline level of PAPP-A for the bodily fluid from the same female. ### Claim 6 (depends on 1) The method of claim 1, wherein detecting the PAPP-A level is performed in an immunoassay using an anti-PAPP-A antibody or antigen binding fragment thereof. ### Claim 7 (depends on 6) The method of claim 6, wherein the anti-PAPP-A antibody is a polyclonal antibody. ### Claim 8 (depends on 6) The method of claim 6, wherein the anti-PAPP-A antibody is a monoclonal antibody. ### Claim 9 (depends on 6) The method of claim 6, wherein the antigen binding antibody fragment is a Fab or F(ab′)2. ### Claim 10 (depends on 6) The method of claim 6, wherein the anti-PAPP-A antibody or antigen binding fragment thereof comprises a detectable label or moiety. ### Claim 11 (depends on 1) The method of claim 1, wherein the PAPP-A level from each day is compared to monitor changes in oocyte maturation in the female, a higher PAPP-A level indicating a more advanced state of oocyte maturation. ### Claim 12 (depends on 1) The method of claim 1, wherein the hormone is chorionic gonadotropin (CG) or luteinizing hormone (LH). ### Claim 13 (depends on 1) The method of claim 1, wherein the hormone is administered within 24 hours after the PAPP-A level shows a decrease after continuous increase for at least two consecutive days. ### Claim 14 (depends on 13) The method of claim 13, wherein the female is a human female and the CH or LH is human chorionic gonadotropin (hCG) or human luteinizing hormone (hLH). ### Claim 15 (depends on 1) The method of claim 1, further comprising, subsequent to administering the hormone to the female, collecting mature oocytes from the female. ### Claim 16 (depends on 15) The method of claim 15, wherein the female is a human female and the CH or LH is human chorionic gonadotropin (hCG) or human luteinizing hormone (hLH). ### Claim 17 (depends on 1) The method of claim 1, wherein the female is a human female and the hormone is human chorionic gonadotropin (hCG) or human luteinizing hormone (hLH). ### Claim 18 A method for assessing oocyte maturation in a female, comprising detecting pregnancy-associated plasma protein (PAPP-A) level in a bodily fluid from the female, wherein the PAPP-A level of the female is detected daily for a least three consecutive days; comparing the PAPP-A level with a control to assess oocyte maturation in the female, the control comprising a previously established baseline PAPP-A level for the bodily fluid of the same female or an average PAPP-A level for the bodily fluid from a healthy fertile non-pregnant female, wherein an increase in the PAPP-A level compared to the control indicates a more advanced state of oocyte maturation and a decrease in the PAPP-A level compared to the control indicates a lesser state of oocyte maturation; and inseminating the female within 36 hours after the PAPP-A level in the female exhibits a decrease after continuous increase for at least two consecutive days. ### Claim 19 (depends on 18) The method of claim 18, wherein the PAPP-A level is the PAPP-A protein level of total PAPP-A, PAPP-A homodimer, or PAPP-A/proMBP heterodimer. ### Claim 20 (depends on 18) The method of claim 18, wherein the bodily fluid is follicular fluid, serum or plasma. ### Claim 21 (depends on 18) The method of claim 18, wherein the control is the average PAPP-A level for the body fluid from a healthy fertile non-pregnant female. ### Claim 22 (depends on 18) The method of claim 18, wherein the control is a previously established baseline level of PAPP-A for the bodily fluid from the same female. ### Claim 23 (depends on 18) The method of claim 18, wherein detecting the PAPP-A level is performed in an immunoassay using an anti-PAPP-A antibody or antigen binding fragment thereof.