NCT03767569

Brief Summary

A randomized controlled trial to evaluate whether pretreatment with myo-inositol can lower testosterone levels and improve clinical outcomes in hyperandrogenic PCOS patients undergoing ART

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

April 6, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

December 6, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

April 6, 2018

Last Update Submit

December 5, 2018

Conditions

PCOSFemale Infertility

Outcome Measures

Primary Outcomes (1)

  • Serum testosterone level after 12 weeks of administration of Myo-Inositol

    2 years

Secondary Outcomes (10)

  • Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol

    2 years

  • Number of mature oocytes

    2 years

  • Embryo quality

    2 years

  • Implantation rate (%)

    2 years

  • Clinical pregnancy rate (%)

    2 years

  • +5 more secondary outcomes

Study Arms (2)

Myo-inositol

EXPERIMENTAL

Pretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology)

Drug: Myo-inositol

Folic acid

OTHER

Folic acid 0.4 mg daily during 12 weeks before start of ART

Drug: Folic Acid

Interventions

Myo-inositolDRUG

Myo-inositol and Folic acid daily

Myo-inositol
Folic AcidDRUG

Folic Acid daily

Folic acid

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-40 years
  • PCOS phenotypes A, B and C
  • Signed informed consent

You may not qualify if:

  • Other relevant endocrine disorders
  • Contraindications to the use of gonadotropins
  • Endometriosis grade 3-4
  • BMI \> 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

InositolFolic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Michel De Vos, PhD

CONTACT

+3224776699michel.devos@uzbrussel.be

Sylvie De Rijdt, MD

CONTACT

sylvie.derijdt@uzbrussel.be

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2018

First Posted

December 6, 2018

Study Start

September 1, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

December 6, 2018

Record last verified: 2018-03

Locations

BE(1)