Composition comprising HP-hMG for use in treating infertility
AssigneeFerring B.V.
InventorsPatrick Heiser, Eric Foster
Life of this patent
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Abstract
The present invention relates to improved assisted reproductive technology for women predicted to have a high ovarian response to controlled ovarian stimulation that comprise targeting a threshold serum hCG level by the final day of stimulation.
Claims19
A method of treating infertility in a patient having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (≥5.0±0.2 ng/ml) prior to treatment/stimulation, comprising:
- selecting a patient identified as having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (≥5.0±0.2 ng/ml) prior to treatment/stimulation;
- conducting controlled ovarian stimulation by administering a daily dose of 75-450 IU highly purified human menopausal gonadotropin (HP-hMG) to the selected patient from day one of treatment;
- at stimulation day 5 or 6 or 7 of controlled ovarian stimulation, determining whether the patient's serum level of human chorionic gonadotrophin (hCG) is at a target mid-follicular threshold level of ≥1.5 mIU/mL;
- and
- maintaining or increasing the daily dose of highly purified human menopausal gonadotropin (HP-hMG) based on whether the patient's serum level of human chorionic gonadotrophin (hCG) is at or below the target mid-follicular threshold level.
A method of treating infertility in a patient having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (≥5.0±0.2 ng/ml) prior to treatment/stimulation, comprising:
- selecting a patient identified as having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (≥5.0±0.2 ng/ml) prior to treatment/stimulation;
- conducting controlled ovarian stimulation by administering a daily dose of 75-450 IU highly purified human menopausal gonadotropin (HP-hMG) to the patient from day one of treatment;
- at stimulation day 5 or 6 or 7, determining if the patient's serum level of human chorionic gonadotrophin (hCG) is at a target mid-follicular threshold level of ≥1.5 mIU/mL;
- and
- triggering final follicular maturation when the level of human chorionic gonadotrophin (hCG) in the patient's serum is at or above a specified threshold level of serum human chorionic gonadotrophin (hCG) for final follicular maturation selected from 1.5-2.0 mIU/mL which leads to an increased probability of live birth.
A method of treating infertility in a patient having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (≥5.0±0.2 ng/ml) prior to treatment/stimulation, comprising:
- selecting a patient identified as having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (>5.0±0.2 ng/ml) prior to treatment/stimulation;
- conducting controlled ovarian stimulation by administering a daily dose of 75-450 IU highly purified human menopausal gonadotropin (HP-hMG) to the patient from day one of treatment;
- at stimulation day 5 or 6 or 7, determining if the patient's serum level of human chorionic gonadotrophin (hCG) is at a target mid-follicular threshold level of ≥1.5 mIU/mL;
- and
- triggering final follicular maturation when the level of human chorionic gonadotrophin (hCG) in the patient's serum is at or above 1.8 mIU/mL which leads to an increased probability of live birth.
A method for increasing a probability of live birth following fresh or frozen embryo transfer in the treatment of infertility in a patient having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (≥5.0±0.2 ng/ml) prior to treatment/stimulation, comprising:
- selecting a patient identified as having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (≥5.0±0.2 ng/ml) prior to treatment/stimulation;
- conducting controlled ovarian stimulation by administering a daily dose of 75-450 IU highly purified human menopausal gonadotropin (HP-hMG) to the patient from day one of treatment;
- at stimulation day 5 or 6 or 7, determining if the patient's serum level of human chorionic gonadotrophin (hCG) is at a target mid-follicular threshold level of ≥1.5 mIU/mL;
- and
- triggering final follicular maturation when the level of human chorionic gonadotrophin (hCG) in the patient's serum is at or above a specified threshold level of serum human chorionic gonadotrophin (hCG) for final follicular maturation selected from 1.5-2.0 mIU/mL which leads to an increased probability of live birth.
A method for increasing a probability of live birth following fresh or frozen embryo transfer in the treatment of infertility in a patient having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (≥5.0±0.2 ng/ml) prior to treatment/stimulation, comprising:
- selecting a patient identified as having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (≥5.0±0.2 ng/ml) prior to treatment/stimulation;
- conducting controlled ovarian stimulation by administering a daily dose of 75-450 IU/day highly purified human menopausal gonadotropin (HP-hMG) to the selected patient from day one of treatment;
- at stimulation day 5 or 6 or 7, determining whether the patient's serum level of human chorionic gonadotrophin (hCG) is at a target mid-follicular threshold level≥1.5 mIU/mL;
- and
- maintaining or increasing the daily dose of highly purified human menopausal gonadotropin (HP-hMG) based on whether the patient's serum level of hCG is at or below the target mid-follicular threshold level.
A method of treating infertility in a patient having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (≥5.0±0.2 ng/ml) prior to treatment/stimulation, comprising:
- selecting a patient identified as having a serum anti-Müllerian hormone (AMH) level≥35.7±0.5 pmol/L (≥5.0±0.2 ng/ml) prior to treatment/stimulation;
- conducting controlled ovarian stimulation by administering a daily dose of 75-450 IU highly purified human menopausal gonadotropin (HP-hMG) to the selected patient from day one of treatment;
- at stimulation day 5 or 6 or 7 of controlled ovarian stimulation, determining whether the patient's serum level of human chorionic gonadotrophin (hCG) is at a target mid-follicular threshold level of ≥1.5 mIU/mL;
- maintaining or increasing the daily dose of highly purified human menopausal gonadotropin (HP-hMG) based on whether the patient's serum level of human chorionic gonadotrophin (hCG) is at or below the target mid-follicular threshold level;
- and
- triggering final follicular maturation when the level of human chorionic gonadotrophin (hCG) in the patient's serum is at or above 1.8 mIU/mL.
Dependencies are inferred from the claim text.