# US 10,478,473 B2 · Compositions and methods of using anti-mullerian hormone for treatment of infertility

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- Number: US 10,478,473 B2
- Document ID: US10478473B2
- Status: Granted
- Kind: B2
- Application number: 15/554,238
- Filed: 2016-02-29
- Published: 2018-08-23
- Granted: 2019-11-19
- Earliest claimed: 2015-03-04
- Assignees: The Center for Human Reproduction (Chr); University of Rochester
- Applicants: University of Rochester; Center for Human Reproduction
- Inventors: Aritro Sen; Norbert Gleicher; Vitaly A. Kushnir
- Web page: https://patentgrep.com/patent/US10478473B2

## CPC

- A61K 38/22: Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35)
- A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377)
- A61K 31/7105: Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
- A61K 38/24: Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 15/08: for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
- C12N 15/1136: {against growth factors, growth regulators, cytokines, lymphokines or hormones}
- C12N 2310/11: Antisense
- C12N 2310/12: catalytic nucleic acids, e.g. ribozymes
- C12N 2310/14: interfering nucleic acids [NA]
- C12N 2310/141: MicroRNAs, miRNAs
- C12N 2310/16: Aptamers
- C12N 2320/31: Combination therapy
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention provides compositions and methods for the treatment of subjects with impaired fertility or at risk for impaired fertility. In certain aspects, the invention relates to increasing the level or activity of anti-Mullerian hormone (AMH) in a subject.

## Claims

### Claim 1

A method for treating infertility in a subject comprising administering to the subject an effective amount of a composition comprising anti-Mullerian hormone (AMH), wherein the AMH comprises the amino acid sequence set forth in SEQ ID NO:1; and wherein the AMH is administered at a dose in the range of about 22,000 ng/day to about 44,000 ng/day for a period of time from about 30 days to about 90 days.

### Claim 2 (depends on 1)

The method of claim 1, wherein infertility in the subject is characterized by at least one selected from the group consisting of diminished ovarian reserve (DOR), natural aging, premature ovarian aging, and gonadotoxic treatment.

### Claim 3 (depends on 1)

The method of claim 1, wherein the subject is human.

### Claim 4

A method of increasing the number of collected oocytes during superovulation in a subject, the method comprising:
a) administering to the subject an effective amount of AMH each day for a first period of time;
b) inducing superovulation in the subject after a second period of time where no AMH is delivered to the subject, wherein the AMH comprises the amino acid sequence set forth in SEQ ID NO: 1.

### Claim 5 (depends on 4)

The method of claim 4, wherein superovulation is induced by administering to the subject at least one selected from the group consisting of a gonadotropin, follicle stimulating hormone (FSH), luteinizing hormone (LH), clomiphene, a selective estrogen-receptor modulator (SERM), and a aromatase inhibitor.

### Claim 6 (depends on 4)

The method of claim 4, wherein the first period of time is in the range of about 1 day to about 90 days.

### Claim 7 (depends on 6)

The method of claim 6, wherein AMR is administered at a dose in the range of about 22,000 ng/day to about 44,000 ng/day, for a first duration of about 90 days.

### Claim 8 (depends on 4)

The method of claim 4, wherein the second period of time is in the range of about 0 days to about 30 days.