Fertility prediction by use of clomiphene challenge test

• US 5,091,170 A
• Filed: 04/06/1989
• Issued: 02/25/1992
• Est. Priority Date: 03/17/1987
• Status: Expired due to Term

• Current Assignee: Daniel Navot
• Original Assignee: Daniel Navot
• Inventors: Navot, Daniel
• Primary Examiner(s): Rosen, Sam
• Application Number:
  US07/334,780
• Time in Patent Office: 1,055 Days
• Field of Search: 436/501, 436/536, 436/65, 436/87, 436/811, 436/906, 530/387, 530/389, 424/9
• US Class Current: 436/65
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function
• CPC Class Codes: Y10S 436/906 Fertility tests

Abstract

The fertility of females, especially human females can be predicted by use of a clomiphene challenge test. The test is based upon comparison of follicle stimulating hormone and/or luteinizing hormone levels in urine or blood samples at two points in the menstrual cycle. The first test is performed on days 2-3 of the cycle. Clomiphene, and most preferably clomiphene in the form of clomiphene citrate, in a dosage of about 100 mg/day, is then administered, preferably on days 5-9. The second test is conducted on days 9-10. The test results are most conveniently compared by colorimetric methods involving monoclonal antibody reactions with follicle stimulating hormone and/or luteininizing hormone.

Claims

1. A method for predicting the fertility or infertility of a human female patient which comprises administering clomiphene to said patient during the period of days 2-9 of said patient'"'"'s menstrual cycle, measuring the follicle stimulating hormone response level of said patient during the period of days 9-11 of said patient'"'"'s menstrual cycle, and comparing said response level to normal response levels, wherein a response level significantly greater than normal response levels is predictive of infertility and a response level within normal response levels is predictive of fertility.

2. The method of claim 1 wherein a follicle stimulating hormone response level greater than two standard deviations above normal response levels is predictive of infertility.

3. The method of claim 1 wherein a follicle stimulating hormone response level greater than 26 mIU/ml is predictive of infertility.

4. The method of claim 1 wherein a follicle stimulating hormone response level of about 11.5±

4.9 mIU/ml is predictive of fertility.

5. The method of claim 1 wherein the clomiphene is administered on days 5-9 of said patient'"'"'s menstrual cycle.

6. The method of claim 5 wherein the clomiphene is administered in dosages of about 50 mg to about 150 mg per day.

7. The method of claim 6 wherein the clomiphene is administered in dosages of about 100 mg per day.

8. The method of claim 7 wherein the clomiphene is clomiphene citrate.

9. A method of predicting the fertility or infertility of a human female patient which comprises:

determining a baseline level for follicle stimulating hormone in the period of days 2-3 of said patient'"'"'s menstrual cycle;

administering clomiphene to said patient during the period of days 2-9 of said patient'"'"'s menstrual cycle;

determining a response level of follicle stimulating hormone in the period of days 9-11 of said patient'"'"'s menstrual cycle; and

comparing said response level to said baseline level, wherein a response level significantly elevated over said baseline level is predictive of infertility.

10. The method of claim 9 wherein a response level more than double the baseline level is predictive of infertility.

11. The method of claim 9 wherein the clomiphene is administered on days 5-9 of said patient'"'"'s menstrual cycle.

12. The method of claim 11 wherein the clomiphene is administered in dosages of about 50 mg to about 150 mg per day.

13. The method of claim 12 wherein the clomiphene is administered in dosages of about 100 mg per day.

14. The method of claim 13 wherein the clomiphene is clomiphene citrate.

15. A method of predicting the fertility or infertility of a human female patient which comprises administering clomiphene to said patient during the period of days 2-9 of said patient'"'"'s menstrual cycle, measuring the luteinizing hormone response level of said patient during the period of days 9-11 of said patient'"'"'s menstrual cycle, and comparing said response level to normal response levels, wherein a response level significantly greater than normal response levels is predictive of infertility.

16. The method of claim 15 wherein the clomiphene is administered in dosages of about 50 mg to about 150 mg per day on days 5-9 of said patient'"'"'s menstrual cycle.

17. A method of predicting the fertility or infertility of a human female patient which comprises administering clomiphene to said patient during the period of days 2-9 of said patient'"'"'s menstrual cycle, measuring the follicle stimulating hormone response level and the luteinizing hormone response level of said patient during the period of days 9-11 of said patient'"'"'s menstrual cycle, and comparing said response levels, wherein a follicle stimulating hormone response level greater than the luteinizing hormone response level is predictive of infertility.

18. The method of claim 17 wherein the clomiphene is administered on days 5-9 of said patient'"'"'s menstrual cycle.

19. The method of claim 18 wherein the clomiphene is administered in dosages of about 50 mg to about 150 mg per day.

20. The method of claim 19 wherein the clomiphene is administered in dosages of about 100 mg per day.

21. The method of claim 20 wherein the clomiphene is clomiphene citrate.