NCT01540747

Brief Summary

To evaluate the effects of melatonin supplementation on the main in vitro fertilization (IVF) outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome (PCOS).

Trial Health

80
On Track

Trial Health Score

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

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

First Submitted

Initial submission to the registry

February 17, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
Last Updated

February 29, 2012

Status Verified

January 1, 2009

First QC Date

February 17, 2012

Last Update Submit

February 23, 2012

Conditions

Polycystic Ovary Syndrome

Keywords

intrafollicular melatoninPCOSembryos qualityoocytes quality

Outcome Measures

Primary Outcomes (4)

  • Number of mature oocytes

  • embryo quality

  • Pregnancy rate

  • Implantation rate

Secondary Outcomes (6)

  • Total dose of FSH administered

  • Number of days of stimulation

  • Serum estradiol levels

  • Endometrial thickness

  • Cancellation rate

  • +1 more secondary outcomes

Study Arms (2)

Inofolic plus

EXPERIMENTAL

178 patients

Dietary Supplement: Myo-inositol + folic acid + melatonin

Inofolic

ACTIVE COMPARATOR

180 patients

Dietary Supplement: Myo-inositol + folic acid

Interventions

Myo-inositol + folic acid + melatoninDIETARY_SUPPLEMENT

Myo-inositol (2000mg)+ folic acid (200 mcg)+ melatonin(3 mg)

Inofolic plus
Myo-inositol + folic acidDIETARY_SUPPLEMENT

Myo-inositol (2000mg) + folic acid (200 mcg)

Inofolic

Eligibility Criteria

Age27 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of PCOS
  • irregular menstrual cycle (\> than 28-30 days)
  • normal uterine cavity
  • body mass index of 20 to 26 Kg/m2
  • first IVF treatment

You may not qualify if:

  • presence of tubal, uterine, genetics and male causes of infertility
  • diagnosis of cancer
  • hormonal treatment in the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxi Pro Vita Centro di Fertilità

Rome, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

InositolFolic AcidMelatonin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTryptaminesIndolesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2012

First Posted

February 29, 2012

Last Updated

February 29, 2012

Record last verified: 2009-01

Locations

IT(1)