NCT01290432

Brief Summary

Dr. Roseff and his colleagues are conducting a study to evaluate the effectiveness of a novel substance (Inofolic Plus®) in improving oocyte (egg) parameters in subfertile female patients, as measured through Anti-Mullerian Hormone (AMH) blood levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

May 25, 2012

Status Verified

May 1, 2012

Enrollment Period

1 year

First QC Date

February 3, 2011

Last Update Submit

May 24, 2012

Conditions

Infertility, Female

Keywords

female fertilityovarian reserveoocyte qualityoocyte quantityantimullerian hormoneAMHdietary supplementsinofolic plusmyoinositolfolic acid

Outcome Measures

Primary Outcomes (1)

  • Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve (AMH Levels)

    Women will receive Infolic Plus nightly for up to 90 days. Baseline AMH blood levels will be analyzed, and AMH titers will be checked monthly thereafter for the 90 day duration of the study.

    Three Months

Study Arms (1)

Inofolic Plus

EXPERIMENTAL

Patients are given Inofolic Plus to see if the AMH changes over a period of up to 90 days.

Dietary Supplement: Inofolic Plus

Interventions

Inofolic PlusDIETARY_SUPPLEMENT

Inofolic Plus contains folic acid and myoinositol and melatonin

Also known as: folic acid, myoinositol, and melatonin in combination
Inofolic Plus

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female between 18 - 42 years of age
  • Diagnosed with "Diminished Ovarian Reserve" (DOR)

You may not qualify if:

  • Ongoing history of illicit drug or tobacco use
  • Ovarian surgery within 90 days of signing the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palm Beach Center for Reproductive Medicine

Wellington, Florida, 33414, United States

Location

Related Publications (4)

  • 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: 18339123BACKGROUND

  • 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: 18804205BACKGROUND

  • 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: 18462730BACKGROUND

  • Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.

    PMID: 19800728BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Interventions

Folic AcidInositolMelatonin

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesTryptaminesIndolesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Scott Roseff, MD

    Palm Beach Center for Reproductive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 7, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

May 25, 2012

Record last verified: 2012-05

Locations

US(1)