IP Library Granted Patent US 9,295,662
Granted Patent B2
US 9,295,662 · App. 14/383,269 · Granted Mar 29, 2016

Methods for enhancing, improving, or increasing fertility or reproductive function

Inventors: Mark Puder (Medfield, MA); Deepika Nehra (Boston, MA); Bo R. Rueda (Windham, NH)
Assignees: Children's Medical Center Corporation; The General Hospital Corporation
A61K31/202A23L1/3008A61K31/232A61K31/593A61K45/06A23V2002/00
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Quick Facts
Patent No.
US 9,295,662
App. No.
14/383,269
Granted
Mar 29, 2016
Kind
B2
Abstract

The present disclosure is directed to methods for enhancing, improving or increasing fertility or reproductive function. For example, the present disclosure is directed to a method for enhancing, improving, or increasing a female human's likelihood of becoming pregnant comprising: administering to the human a nutritional, dietary, or food fatty acid supplement comprising: at least 30% docosahexaenoic acid (DHA), by weight of the total fatty acids in the supplement in a form chosen from ethyl ester, free fatty acid, and triglyceride.

Claims (41)

1. A method for enhancing, improving, or increasing a female human's likelihood of becoming pregnant comprising:

administering to the human a nutritional, dietary, or food fatty acid supplement comprising:

at least 30% docosahexaenoic acid (DHA), by weight of the total fatty acids in the supplement in a form chosen from ethyl ester, free fatty acid, and triglyceride.

2. The method according to claim 1 , wherein the supplement further comprises eicosapentaenoic acid (EPA) in a form chosen from ethyl ester, free fatty acid, and triglyceride.

3. The method according to claim 1 or 2 , wherein the supplement further comprises arachidonic acid in a form chosen from ethyl ester, free fatty acid, and triglyceride.

4. The method of according to claim 1 , wherein the DHA is in the form of triglyceride.

5. The method according to claim 1 , wherein the supplement further comprises vitamin D.

6. The method according to claim 5 , wherein the vitamin D is present in an amount ranging from about 400 to about 4000 International Units (IU), from about 1000 to about 4000 IU, or from about 2000 to about 4000 IU.

7. The method according to claim 5 , wherein the supplement further comprises at least one vitamin other than vitamin D.

8. The method according to claim 2 , wherein the weight ratio of the DHA to the EPA ranges from about 500:1, 100:1, 50:1, 20:1, 15:1, 10:1, 9:1, 8:1, 7:1, 6:1, 5:1, 4:1, 3:1, 2:1, to 1:1.

9. The method according to claim 3 , wherein the weight ratio of the omega-3 fatty acids to the omega-6 fatty acids is about 10:1 or greater.

10. The method according to claim 9 , wherein the weight ratio of the omega-3 fatty acids to omega-6 fatty acids is about 20:1, 21:1, 22:1, 23:1, 24:1, 25:1 or greater.

11. The method according to claim 2 , wherein DHA is present in an amount greater than EPA.

12. The method according to claim 11 , wherein DHA is present in an amount ranging from about 500 mg to about 750 mg, and EPA is present in an amount ranging from about 80 mg to about 250 mg.

13. The method according to claim 12 , wherein DHA:EPA are present in a weight ratio chosen from about 70:10, 500:200, and 600-750:150-250.

14. The method according to claim 2 , wherein the supplement comprises from about 650 mg to about 750 mg DHA and from about 80 mg to about 130 mg EPA.

15. The method according to claim 1 , wherein the supplement comprises from about 750 mg to about 900 mg total omega-3 fatty acids.

16. The method according to claim 1 , wherein the supplement further comprises at least one antioxidant.

17. The method according to claim 16 , wherein the at least one antioxidant is chosen from α-tocopherol (vitamin E), calcium disodium EDTA, alpha tocoferyl acetates, butylhydroxytoluenes (BHT), butylhydroxyanisoles (BHA), ascorbic acid and pharmaceutically acceptable salts and esters thereof, propyl gallate, citric acid and pharmaceutically acceptable salts thereof, malic acid and pharmaceutically acceptable salts thereof, and sulfite salts and mixtures thereof.

18. The method according to claim 17 , wherein the at least one antioxidant comprises BHA.

19. The method according to claim 1 , wherein the total omega-3 fatty acids are at least 70%, at least 75%, at least 80%, or at least 90%, by weight of the total fatty acids in the supplement.

20. The method according to claim 2 , wherein DHA and EPA are present in an amount chosen from about 35% to about 90% by weight of the total fatty acids in the supplement, from about 40% to about 85% by weight of the total fatty acids in the supplement, from about 40% to about 80% by weight of the total fatty acids in the supplement, and from about 50% to about 80% by weight of the total fatty acids in the supplement.

21. The method according to claim 1 , wherein the supplement comprises at least one other fatty acid other than DHA in a form chosen from ethyl ester, free fatty acid, and triglyceride.

22. The method according to claim 2 , wherein the supplement further comprises: eicosapentaenoic acid (EPA) in a form chosen from ethyl ester, free fatty acid, and triglyceride, wherein DHA is present in an amount greater than EPA; and arachidonic acid in a form chosen from ethyl ester, free fatty acid, and triglyceride, wherein the weight ratio of omega-3 fatty acids to omega-6 fatty acids is 10:1 or greater.

23. The method according to claim 1 , wherein the daily dosage per day of the total fatty acids in the supplement ranges from 1 to 8 grams.

24. The method according to claim 1 , wherein DHA is present in an amount of at least 90% by weight of the total fatty acids in the supplement.

25. The method according to claim 1 including maintaining or improving oocyte and/or ovum quality in a human in need thereof.

26. The method according to claim 1 , wherein the oocyte and/or ovum quality is maintained or improved by decreasing the likelihood of abnormalities in at least one of spindle integrity and mitochondrial dynamics in the oocyte and/or ovum.

27. The method according to claim 1 , wherein the oocyte and/or ovum quality is maintained or improved by decreasing the likelihood of at least one chromosomal abnormality in the oocyte and/or ovum.

28. The method according to claim 27 , wherein the at least one chromosomal abnormality is chosen from 22q11.2 deletion syndrome, Angelman syndrome, Canavan disease, Coeliac disease, Charcot-Marie-Tooth disease, color blindness, Cri du chat, Cystic fibrosis, Down Syndrome, Duchenne muscular dystrophy, Haemochromatosis, Haemophilia, Klinefelter's syndrome, Neurofibromatosis, Phenylketonuria, Polycystic kidney disease, Prader-Willi syndrome, Sickle-cell disease, Tay-Sachs disease, and Turner syndrome.

29. The method according to claim 1 , wherein the supplement is enterally or parenterally administered.

30. The method of claim 29 , wherein the supplement is enterally administrated and the enteral administration is chosen from oral, gastric, and rectal.

31. The method according to claim 1 , wherein the human is undergoing infertility treatment.

32. The method according to claim 1 , including enhancing and/or prolonging fertility and/or reproductive function in a female human or animal in need thereof.

33. The method according to claim 1 , including delaying the onset of menopause in a female human or animal in need thereof.

34. The method according to claim 1 , the method comprising;

administering the nutritional, dietary or supplement to a subject having a serum level ratio of omega-3 fatty acids to omega-6 fatty acids of 1:1 or less.

35. The method of claim 34 , further comprising determining the serum level ratio of omega-3 fatty acids to omega-6 fatty acids after administering the nutritional, dietary or supplement; and

administering additional doses of the nutritional, dietary or supplement comprising an omega-3 fatty acid when the subject is determined to have a serum level ratio of omega-3 fatty acids to omega-6 fatty acids of 1:1 or less.

36. The method of claim 35 , further comprising determining the serum level ratio of omega-3 fatty acids to omega-6 fatty acids; and

administering doses of the composition comprising an omega-3 fatty acid until the subject is determined to have a serum level ratio of omega-3 fatty acids to omega-6 fatty acids of greater than 1:1.

Assignments (3)
CONFIRMATORY LICENSE Recorded Oct 29, 2015
From: MASSACHUSETTS GENERAL HOSPITAL
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 037007/0398 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2014
From: RUEDA, BO R.
To: THE GENERAL HOSPITAL CORPORATION
Reel/Frame 033799/0423 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2014
From: PUDER, MARK; NEHRA, DEEPIKA
To: CHILDREN'S MEDICAL CENTER CORPORATION
Reel/Frame 033799/0438 →
Continuity (3)
Provisional Application 61607884 · Mar 7, 2012
Provisional Application 61695510 · Aug 31, 2012
Related Publication 20150025048A1 · Jan 22, 2015