A method of administering elagolix to a patient in association with an artificial reproductive technology (ART) protocol involves orally administering 150 to 400 mg elagolix per day. In accordance with certain embodiments, the method further involves the co-administration of exogenous gonadotropins (rFSH or HMG) with a subsequent ovulatory trigger. In an embodiment, the patient is administered 150 to 200 mg Elagolix PO daily or twice per day. In an embodiment, the patient is administered 150 to 200 mg Elagolix PO per day at a dosing duration of a minimum of one day and a maximum of six days. In an embodiment, the ART protocol involves administering 150 to 200 mg Elagolix PO per day based upon a patient's transvaginal ultrasound and hormone levels.

An approach is disclosed for improving oocytes quality by increasing a follicular phase of an ovarian cycle of a patient. A target duration of the follicular phase of the patient is determined. The follicular phase is extended to improve the quality of the oocyte which improves the change of reproductive success. Non-steroidal anti-inflammatory medications is prescribed to be consumed for at least one day during the target duration by the patient. A plurality of ovary stimulating medications to be consumed only during the target duration to stimulate ovaries of the patient. Oocytes are harvested after achieving the target duration and a fertilization method is prescribed.

An approach is disclosed for improving oocytes quality by increasing a follicular phase of an ovarian cycle of a patient. A target duration of the follicular phase of the patient is determined. The follicular phase is extended to improve the quality of the oocyte which improves the change of reproductive success. Non-steroidal anti-inflammatory medications is prescribed to be consumed for at least one day during the target duration by the patient. A plurality of ovary stimulating medications to be consumed only during the target duration to stimulate ovaries of the patient. Oocytes are harvested after achieving the target duration and a fertilization method is prescribed.

The disclosure provides compositions and methods for determining the propensity of a subject (e.g., a female human subject) undergoing embryo transfer therapy to benefit from administration of an oxytocin receptor antagonist, as well as for treating such patients accordingly. Using the compositions and methods of the disclosure, a subject undergoing embryo transfer therapy may be selected for treatment with an oxytocin receptor antagonist on the basis of a pre-treatment gene signature. Additionally or alternatively, a subject that is undergoing embryo transfer therapy and that has been administered an oxytocin receptor antagonist may be monitored following treatment to determine whether the subject is responding to the oxytocin receptor antagonist or if subsequent dosing is desirable. Exemplary oxytocin receptor antagonists useful in conjunction with the compositions and methods of the disclosure include pyrrolidin-3-one oxime compounds, such as (3Z,5S)-5-(hydroxymethyl)-1-[(2′-methyl-1,1′-biphenyl-4-yl)carbonyl]pyrrolidin-3-one O-methyloxime, among others.

The disclosure provides compositions and methods for determining the propensity of a subject (e.g., a female human subject) undergoing embryo transfer therapy to benefit from administration of an oxytocin receptor antagonist, as well as for treating such patients accordingly. Using the compositions and methods of the disclosure, a subject undergoing embryo transfer therapy may be selected for treatment with an oxytocin receptor antagonist on the basis of a pre-treatment gene signature. Additionally or alternatively, a subject that is undergoing embryo transfer therapy and that has been administered an oxytocin receptor antagonist may be monitored following treatment to determine whether the subject is responding to the oxytocin receptor antagonist or if subsequent dosing is desirable. Exemplary oxytocin receptor antagonists useful in conjunction with the compositions and methods of the disclosure include pyrrolidin-3-one oxime compounds, such as (3Z,5S)-5-(hydroxymethyl)-1-[(2′-methyl-1,1′-biphenyl-4-yl)carbonyl]pyrrolidin-3-one O-methyloxime, among others.

Methods for non-invasive retrieval of viable (i.e., able to be fertilized) oocytes from the uterus via a combination of unique ovarian stimulation and uterine lavage technology. These methods may eliminate the need for an invasive surgical procedure. Embodiments include the use of a novel hormonal protocol, including the use of injectable gonadotropins, to induce the release of immature oocytes from the ovaries of a patient. The immature oocytes mature as they transit the fallopian tubes such that mature, viable oocytes may be collected from the uterus via a uterine lavage procedure. Further embodiments include the use of a novel hormonal protocol, including the administration of Prostaglandins, Estradiol, and/or Progesterone Blockers, to accelerate transport of oocytes through the fallopian tubes. Further embodiments include kits for uterine lavage, compositions suitable for triggering and inducing superovulation, and compositions suitable for accelerating tubal transport of mature oocytes in a female patient.

Methods for non-invasive retrieval of viable (i.e., able to be fertilized) oocytes from the uterus via a combination of unique ovarian stimulation and uterine lavage technology. These methods may eliminate the need for an invasive surgical procedure. Embodiments include the use of a novel hormonal protocol, including the use of injectable gonadotropins, to induce the release of immature oocytes from the ovaries of a patient. The immature oocytes mature as they transit the fallopian tubes such that mature, viable oocytes may be collected from the uterus via a uterine lavage procedure. Further embodiments include the use of a novel hormonal protocol, including the administration of Prostaglandins, Estradiol, and/or Progesterone Blockers, to accelerate transport of oocytes through the fallopian tubes. Further embodiments include kits for uterine lavage, compositions suitable for triggering and inducing superovulation, and compositions suitable for accelerating tubal transport of mature oocytes in a female patient.

Disclosed herein is a method of identifying and/or addressing incipient preeclampsia in a patient-subject by the steps of (a) performing a bioassay to determine the level of at least one sialyl Lewis antigen in a said patient-subject at about 25 weeks of pregnancy or earlier; (b) performing a bioassay to determine the level of at least one sialyl Lewis antigen in a pregnant non-preeclampsia one or more subjects at about 30 weeks of pregnancy or later, wherein said at least one sialyl Lewis antigen assay is for a sialyl Lewis antigen assayed in step (a) is and if more than one subject is assayed, averaging said results; and (c) managing said patient-subject for preeclampsia, if said level of at least one sialyl Lewis antigen of step (a) is at or greater than about 20% above the level of such silalyl Lewis antigen assayed in step (b).

Disclosed herein is a method of identifying and/or addressing incipient preeclampsia in a patient-subject by the steps of (a) performing a bioassay to determine the level of at least one sialyl Lewis antigen in a said patient-subject at about 25 weeks of pregnancy or earlier; (b) performing a bioassay to determine the level of at least one sialyl Lewis antigen in a pregnant non-preeclampsia one or more subjects at about 30 weeks of pregnancy or later, wherein said at least one sialyl Lewis antigen assay is for a sialyl Lewis antigen assayed in step (a) is and if more than one subject is assayed, averaging said results; and (c) managing said patient-subject for preeclampsia, if said level of at least one sialyl Lewis antigen of step (a) is at or greater than about 20% above the level of such silalyl Lewis antigen assayed in step (b).

The present invention provides compositions comprising one or more active pharmaceutical ingredients, wherein the compositions are in the form of high solids concentration pastes capable of being injected in relatively low volumes into an animal using standard commercially available syringes. The invention also provides methods of making such compositions, particularly those compositions comprising high molecular weight active ingredients (e.g., antibodies, enzymes and other proteins and peptides) at relatively high therapeutic concentrations in the high solids concentration pastes. The invention further provides methods of using such formulations in treating, preventing and/or ameliorating certain diseases and physical disorders in animals, including humans, in need thereof. The invention also provides kits comprising the formulations of the invention and a suitable syringe, which in some aspects may be pre-loaded or pre-filled with a composition of the invention.