NCT03667443

Brief Summary

The investigator's aim is to evaluate if the combination of myo-inositol and alpha-lactalbumin can overcome the resistance to myo-inositol in PCOS patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

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

August 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
3.8 years until next milestone

Study Start

First participant enrolled

June 13, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

July 11, 2025

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

August 1, 2018

Last Update Submit

July 8, 2025

Conditions

PCOSMyo-inositol-resistance

Keywords

myo-inositolalpha-lactalbuminpolycystic ovary syndromeanovulationinfertility

Outcome Measures

Primary Outcomes (1)

  • ovulation induction

    Ovulation indaction will by evaluated through ultrasound sonography

    after three months of treatment

Study Arms (2)

Myo-inositol plus folic

ACTIVE COMPARATOR
Dietary Supplement: Myo-inositol + folic a.

Myo-inositol + folic a. + α-lactalbumin

ACTIVE COMPARATOR
Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin

Interventions

Myo-inositol + folic a. + α-lactalbuminDIETARY_SUPPLEMENT

3 months of treatment

Also known as: Inofolic HP
Myo-inositol + folic a. + α-lactalbumin
Myo-inositol + folic a.DIETARY_SUPPLEMENT

3 months of treatment

Also known as: Inofolic
Myo-inositol plus folic

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • POCS women diagnosed using the Rotterdam Criteria

You may not qualify if:

  • Amenorrhea (3 months)
  • Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome
  • Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation
  • Drastic changes in diet
  • Treatment with product containing Myo-inositol in the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aleksandrovska University Hospital

Sofia, Bulgaria

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeAnovulationInfertility

Interventions

Inositol

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 ChemicalsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

September 12, 2018

Study Start

June 13, 2022

Primary Completion

October 26, 2022

Study Completion

December 19, 2022

Last Updated

July 11, 2025

Record last verified: 2023-01

Locations

BU(1)