Single-injection methods and formulations to induce and control multiple ovarian follicles in bovine, caprine, ovine, camelid and other female animals
Methods and formulations for a simplified, single-injection method to induce and control the synchronous growth (superstimulation), and ovulation (superovulation) of multiple ovarian follicles in bovine, ovine, caprine, camelid and other female animals enabling the subsequent collection of (a) multiple oocytes when conducting in-vitro fertilization, or (b) multiple embryos when conducting multiple ovulation embryo transfer.
1 . An injectable drug formulation for inducing ovarian follicular hyperstimulation and superovulation in bovine, caprine, ovine, camelid and other female animals, the formulation comprising:
an in-situ depot formulation comprising a protein microsphere matrix having a diameter ranging from 50-100 microns to a bovine animal, the protein microsphere matrix including controlled release agents, the controlled release agents including a single dose of recombinant follicle stimulating hormone (FSH) released over 96 hours beginning 48 hours after administration, and two doses of luteinizing hormone (LH), wherein the first dose of LH provides an immediate surge of LH and the second dose provides at least one calculated LH release (burst) after 144 hours from administration of the protein microsphere matrix,
wherein the drug formulation is configured to be administered in a single administration of said protein microsphere matrix to a bovine animal, thereby inducing ovarian follicular hyperstimulation and superovulation of the bovine animal when administered to the bovine animal,
wherein the protein microsphere matrix comprises at last one polymer, wherein the at least one polymer is selected from a group consisting of polyethylene glycol (PEG), poly(lactic acid) (PLA) or poly(lactide-co-glycolide) (PLGA).
2 . The formulation of claim 1 , wherein the formulation is a suspension or an extended release powder for suspension.
3 . The formulation of claim 1 , wherein the dose of recombinant FSH is 75 IU and the dose of LH is 50 mg.
4 . The method of claim 1 , wherein the first dose of LH provides a surge (burst) of LH between hours 0-12 from administration of the protein microsphere matrix.
5 . The formulation of claim 1 , wherein the second dose of LH provides two or more calculated LH releases.
6 . The formulation of claim 1 , wherein the second dose of LH provides 2-8 calculated LH releases between hours 145-182 from administration of the protein microsphere matrix.
7 . The formulation of claim 1 , wherein administration of the formulation to a bovine animal causes at least two primordial follicles in a bovine animal to mature simultaneously.
8 . The formulation of claim 1 , wherein recombinant FSH is provided at a prescribed rate for hours 48-144 post administration.
9 . The formulation of claim 1 , wherein the dose of recombinant FSH ranges from 35 to 75 IU.