Myo-inositol Plus Melatonin in Perimenopausal Women

NCT01325389 | Unknown

• 1 other identifier: Myo+MEL_peri_women
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Menopause is the milestone of a more broaden condition that can last up to 10 years. The first menopausal symptoms usually appear around the age of 42 and are characterized by a gradual decline in thyroid and gonadal function with a progressive increase of plasmatic luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels. Recent studies have shown that myo-inositol and melatonin play a major role in ovarian homeostasis. In particular, it has been demonstrated that myo-inositol and/or melatonin supplementation lead to an increase of oocyte quality. Additional studies focused on postmenopausal women have shown that myo-inositol is able to ameliorate the metabolic syndrome that often affects these patients, thus reducing the risk of cardiovascular diseases (CVDs). The aim of the present study is to evaluate whether myo-inositol and melatonin might play a positive role in regulating hormonal levels during menopausal onset.

Conditions

Perimenopause

Study Arms (2)

Myo+Mel

EXPERIMENTAL

Patients are treated with 2g of myo + 3mg of melatonin daily

Dietary Supplement: Myo-Mel

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Myo-Mel DIETARY_SUPPLEMENT

Myo+Mel

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 42 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• FSH between 15 and 50 IU/ml on the 5th day of the menses
• Oligomenorrhea

Sponsors & Collaborators

• AGUNCO Obstetrics and Gynecology Centre: lead

Study Sites (1)

AGUNCO

Rome, 00155, Italy

RECRUITING

Related Publications (5)

• Papaleo E, Unfer V, Baillargeon JP, Fusi F, Occhi F, De Santis L. RETRACTED: Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial. Fertil Steril. 2009 May;91(5):1750-1754. doi: 10.1016/j.fertnstert.2008.01.088. Epub 2008 May 7.

  PMID: 18462730 BACKGROUND

• Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci. 2010 Jun;14(6):555-61.

  PMID: 20712264 BACKGROUND

• Giordano D, Corrado F, Santamaria A, Quattrone S, Pintaudi B, Di Benedetto A, D'Anna R. Effects of myo-inositol supplementation in postmenopausal women with metabolic syndrome: a perspective, randomized, placebo-controlled study. Menopause. 2011 Jan;18(1):102-4. doi: 10.1097/gme.0b013e3181e8e1b1.

  PMID: 20811299 BACKGROUND

• Tamura H, Nakamura Y, Korkmaz A, Manchester LC, Tan DX, Sugino N, Reiter RJ. Melatonin and the ovary: physiological and pathophysiological implications. Fertil Steril. 2009 Jul;92(1):328-43. doi: 10.1016/j.fertnstert.2008.05.016. Epub 2008 Sep 18.

  PMID: 18804205 BACKGROUND

• Tamura H, Takasaki A, Miwa I, Taniguchi K, Maekawa R, Asada H, Taketani T, Matsuoka A, Yamagata Y, Shimamura K, Morioka H, Ishikawa H, Reiter RJ, Sugino N. Oxidative stress impairs oocyte quality and melatonin protects oocytes from free radical damage and improves fertilization rate. J Pineal Res. 2008 Apr;44(3):280-7. doi: 10.1111/j.1600-079X.2007.00524.x.

  PMID: 18339123 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 29, 2011
• Last Updated: March 29, 2011

Record last verified: 2011-03

Locations

IT (1)