Estrus Synchronization Preparations & Effective CIDR-Less Protocols

Abstract

An injectable preparation of estrogenic and progestrogenic hormonal compounds in an anhydrous excipient injected to synchronize estrus in non-menstruating placental female animals, and a five to nine day protocol to apply the unique preparation to achieve estrus synchronization.

We claim: 
     
         1 . An injectable preparation, administered by intramuscular injection, for promoting CIDR-less estrus synchronization in healthy, mature, cycling female cattle, comprising: (a) a steroidal estrogenic compound such as, for example, estradiol 17-β, estradiol benzoate, or any derivatives, analogs, or agonists thereof, and any combinations thereof, in an amount effective to induce estrus in healthy, mature, cycling female cattle; and (b) a steroidal progestin such as, for example, progesterone, hydroxyprogesterone, medroxyprogesterone, altrenogest, norgestomet, levonorgestrel, or other progestogenic compound or any derivatives, analogs, or agonists thereof, and any combinations thereof, for preserving the corpus luteum intact for a period of at least five days after its injection; and (c) an anhydrous excipient compounded with said estrogenic compound and said progestin to produce a compound suitable for intramuscular injection. 
     
     
         2 . A preparation as in  claim 1 , wherein said progestogenic concentrations are at least 30 mg/mL after compounding. 
     
     
         3 . A preparation as claimed in  claim 1 , wherein said estrogenic compound, said progestin, and said excipient are combined in quantities such that the said estrogenic compound is in concentrations of at least 0.025% by volume relative to the overall injectable preparation. 
     
     
         4 . A preparation as claimed in  claim 1 , wherein the said estrogenic compound and the said progestin are combined in volumes such that the said estrogenic compound is in concentrations in the range of from 0.05 to 1.0% by volume relative to the overall volume of the injectable preparation. 
     
     
         5 . A preparation as claimed in  claim 1 , wherein the said estrogenic compound and the said progestin are combined in volumes such that the said estrogenic compound is in concentrations in the range of from 0.06 to 0.125% by volume relative to the overall volume of the injectable preparation. 
     
     
         6 . A CIDR®-less method for improving estrus synchronization and fertilization rates in one or more healthy, mature, cycling, female cattle that are at least 45 days postpartum—without utilizing an intravaginal hormone dispensing device—where the method comprises the sequential steps of:
 (a) administering, on Day Zero, by intramuscular injection to each of the healthy, mature, cycling, female cattle a first steroidal hormone preparation comprising a combination of an estrogenic compound and a progestin compounded in an anhydrous excipient, to induce estrus in healthy, mature, cycling, female cattle; and 
 (b) thereafter, sometime on Day X (where Day X is from 5 to 8 days after Day Zero), administering a second preparation comprising prostaglandin, or its biologically functional equivalent, to each of the healthy, mature, cycling, female cattle in an amount effective to initiate estrus; and 
 (c) thereafter, from 12 to 36 hours after administering said second preparation, administering to each of the healthy, mature, cycling, female cattle a third preparation comprising an estrogenic compound in an amount to force ovulation. 
 
     
     
         7 . The method of  claim 6 , further comprising the additional step of attempting to impregnate each of the healthy, mature, cycling, female cattle on Day Z not less than twelve hours after administering said third preparation. 
     
     
         8 . The method of  claim 7  wherein said first steroidal hormone preparation comprising a combination of an estrogenic compound and a progestin to induce estrus in healthy, mature, cycling, female cattle is administered within the first twelve hours on Day Zero, said second preparation is administered within four hours of 8:00 am on Day X where Day X is 6 to 7 days after Day Zero, the said third preparation is administered within four hours of 1:00 pm on Day Y, and the said attempting to impregnate step comprises artificial insemination within four hours of 2:00 pm on Day Z. 
     
     
         9 . The method of  claim 8  wherein said first steroidal hormone preparation comprising a combination of an estrogenic compound and a progestin to induce estrus in healthy, mature, cycling, female cattle is administered within the first twelve hours on Day Zero, said second preparation is administered within one hour of 9:00 am on Day X where Day X is 6 days after Day Zero, the said third preparation is administered within one hour of 1:00 pm on Day Y, and the said insemination is performed within one hour of 2:00 pm on Day Z. 
     
     
         10 . The method of  claim 6  wherein the said first steroidal hormone preparation is an injectable preparation, administered by intramuscular injection, for promoting CIDR-less estrus synchronization in healthy, mature, cycling female cattle, comprising: (a) a steroidal estrogenic compound such as, for example, estradiol 17-β, estradiol benzoate, or any derivatives, analogs, or agonists thereof, and any combinations thereof, in an amount effective to induce estrus in healthy, mature, cycling female cattle; and (b) a steroidal progestin such as, for example, progesterone, hydroxyprogesterone, medroxyprogesterone, altrenogest, norgestomet, levonorgestrel, or other progestogenic compound or any derivatives, analogs, or agonists thereof, and any combinations thereof, for preserving the corpus luteum intact for a period of at least five days after its injection; and (c) an excipient compounded with said estrogenic compound and said progestin to produce a compound suitable for intramuscular injection. 
     
     
         11 . The method of  claim 6  wherein the said first steroidal hormone preparation is an injectable preparation, administered by intramuscular injection, for promoting CIDR-less estrus synchronization in healthy, mature, cycling female cattle, comprising: (a) a steroidal estrogenic compound such as, for example, estradiol 17-β, estradiol benzoate, or any derivatives, analogs, or agonists thereof, and any combinations thereof, in an amount effective to induce estrus in healthy, mature, cycling female cattle; and (b) a steroidal progestin such as, for example, progesterone, hydroxyprogesterone, medroxyprogesterone, altrenogest, norgestomet, levonorgestrel, or other progestogenic compound or any derivatives, analogs, or agonists thereof, and any combinations thereof, for preserving the corpus luteum intact for a period of at least five days after its injection; and (c) an anhydrous excipient compounded with said estrogenic compound and said progestin to produce a compound suitable for intramuscular injection, and further, wherein said estrogenic compound, said progestin, and said excipient are combined in quantities such that the said estrogenic compound is in concentrations in the range of from 0.05% to 1.0% by volume relative to the overall injectable preparation. 
     
     
         12 . The method of  claim 7  wherein the said first steroidal hormone preparation is an injectable preparation, administered by intramuscular injection, for promoting CIDR-less estrus synchronization in healthy, mature, cycling female cattle, comprising: (a) a steroidal estrogenic compound such as, for example, estradiol 17-β, estradiol benzoate, or any derivatives, analogs, or agonists thereof, and any combinations thereof, in an amount effective to induce estrus in healthy, mature, cycling female cattle; and (b) a steroidal progestin such as, for example, progesterone, hydroxyprogesterone, medroxyprogesterone, altrenogest, norgestomet, levonorgestrel, or other progestogenic compound or any derivatives, analogs, or agonists thereof, and any combinations thereof, for preserving the corpus luteum intact for a period of at least five days after its injection; and (c) an excipient compounded with said estrogenic compound and said progestin to produce a compound suitable for intramuscular injection, and further, wherein the said estrogenic compound and the said progestin are combined in volumes such that the said estrogenic compound is in concentrations in the range of from 0.06 to 0.125% by volume relative to the overall volume of the injectable preparation. 
     
     
         13 . A method for improving estrus synchronization and fertilization rates in one or more healthy, virgin heifers—without utilizing an intravaginal hormone dispensing device—where the method comprises the sequential steps of:
 (a) administering, on Day Zero, by intramuscular injection to each of the healthy, virgin heifers a first steroidal hormone preparation comprising a combination of an estrogenic compound and a progestin to induce estrus in healthy, virgin heifers; and 
 (b) thereafter, sometime on Day X (where Day X is 5 to 8 days after Day Zero), administering a second preparation comprising prostaglandin, or its equivalent, to each of the healthy, virgin heifers in an amount effective to initiate estrus; and 
 (c) thereafter, sometime on Day Y (where Day Y is one day later than Day X) but not less than 12 hours after administering said second preparation, administering to each of the healthy, virgin heifers a third preparation comprising an estrogenic compound in an amount to force ovulation; and 
 (d) thereafter, sometime on Day Z (where Day Z is one day later than Day Y) but not less than 12 hours after administering said third preparation, inseminating each of the healthy, virgin heifers. 
 
     
     
         14 . The method of  claim 13  wherein said first steroidal hormone preparation comprising a combination of an estrogenic compound and a progestin to induce estrus in healthy, virgin heifers is administered within the first twelve hours on Day Zero, said second preparation is administered within four hours of 8:00 am on Day X where Day X is 6 to 7 days after Day Zero, the said third preparation is administered within four hours of 1:00 pm on Day Y, and the said insemination is performed within four hours of 2:00 pm on Day Z. 
     
     
         15 . The method of  claim 14  wherein said first steroidal hormone preparation comprising a combination of an estrogenic compound and a progestin to induce estrus in healthy, virgin heifers is administered within the first twelve hours on Day Zero, said second preparation is administered within one hour of 9:00 am on Day X where Day X is 6 days after Day Zero, the said third preparation is administered within one hour of 1:00 pm on Day Y, and the said insemination is performed within one hour of 2:00 pm on Day Z.