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Claims for Patent: 4,845,077

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Claims for Patent: 4,845,077

Title: Method of inducing ovulation
Abstract:A method of inducing ovulation by administering exogenous human menopausal gonadotropins employs FSH as the exogenous human menopausal gonadotripin in the absence of exogenous LH, preferably in conjunction with a gonadotropin releasing factor antagonists. One particular application of the method is in vitro fertilization.
Inventor(s): Hodgen; Gary D. (Potomac, MD)
Assignee: Serono Laboratories, Inc. (Randolph, MA)
Application Number:07/071,521
Patent Claims: 1. In the method of inducing gametogenic follicle growth by parentally administering exogeneous human menopausal gonadotropins which is a combination of FSH and LH in conjunction with human chorionic gonadotropin to a menstruating primate female, the improvement which comprises employing FSH as said exogeneous gonadotropin in the absence of exogeneous LH and administering a gonadotropin releasing hormone antagonist in an amount sufficient to suppress the endogeneous FSH and LH secretion of said female cojointly with said FSH.

2. The method of claim 1, wherein the daily amount of FSH is about 75-225 I.U.

3. The method of claim 2, wherein the daily amount of FSH is about 1.5-4.0 I.U./kg.

4. The method of claim 1, wherein the ovulated follicles collected.

5. The method of claim 1, wherein the daily amount of the gonadotropin releasing hormone antagonist is about 1.0-3.0 mg/kg.

6. The method of claim 1, wherein the daily amount of the gonadotropin releasing hormone antagonist is about 1.5-2.5 mg/kg and the FSH is about 1.5-4.0 I.U./kg.

7. The method of claim 1, wherein the gonadotropin releasing hormone antagonist is (Ac-pClPhe.sup.1 , pClPhe.sup.2, DTrp.sup.3, DArg.sup.6, DAla.sup.10)GnRH HCl.

8. In the method of in vitro fertilization in which ovulation is induced by parenterally administering exogeneous human menopausal gonadotropins which is a combination of FSH and LH to an endocrinologically normal human female in conjunction with human chorionic gonadotropin and the ova realized thereby are collected, the improvement which comprises administering FSH as said exogeneous gonadotropin in the absence of exogeneous LH co-jointly with a gonadotropin releasing hormone antagonist in an amount sufficient to suppress the endogeneous FSH and LH secretion of said female.

9. The method of claim 8, wherein the daily amount of FSH is about 75-225/I.U.

10. The method of claim 9, wherein the daily amount of gonadotropin releasing hormone antagonist is about 1.0-4.0 mg/kg.

11. The method of claim 8, wherein the daily amount of the gonadotropin releasing hormone antagonist is about 1.5-2.5 mg/kg and the FSH is about 1.5-4.0 I.U./kg.

12. The method of claim 10, wherein the gonadotropin releasing hormone antagonist is (Ac-pClPhe.sup.1 , pClPhe.sup.2, DTrp.sup.3, DArg.sup.6, DAla.sup.10)GnRH HCl.

13. A method of suppressing estrogen variability in response to gonadotropin treatment in a primate female which comprises the step of administering a gonadotropin-releasing hormone antagonist in an amount sufficient to suppress the endogenous FSH and LH secretion of said female cojointly with said gonadotropin treatment.

14. The method of claim 13 wherein the gonadotropin treatment comprises administration of a gonadotropin preparation consisting essentially of either (a) FSH alone or (b) FSH and LH in combination.

15. The method of claim 14 wherein the preparation is (b) and contains approximately equal I.U. amounts of FSH and LH.

16. The method of claim 14 comprising the daily administration of about 75 to about 225 I.U. of FSH.

17. The method of claim 14 comprising the daily administration of about 1.5 to about 4.0 I.U./kg FSH.

18. The method of claim 13 wherein the daily administration of about 1.5 to about 4.0 mg/kg FSH.
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