Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients

NCT ID: NCT03767569

Last Updated: 2018-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-04-30

Brief Summary

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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

Detailed Description

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Conditions

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PCOS Female Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Myo-inositol

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

Group Type EXPERIMENTAL

Myo-inositol

Intervention Type DRUG

Myo-inositol and Folic acid daily

Folic acid

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

Group Type OTHER

Folic Acid

Intervention Type DRUG

Folic Acid daily

Interventions

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Myo-inositol

Myo-inositol and Folic acid daily

Intervention Type DRUG

Folic Acid

Folic Acid daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Other relevant endocrine disorders
* Contraindications to the use of gonadotropins
* Endometriosis grade 3-4
* BMI \> 35
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Michel De Vos, PhD

Role: CONTACT

+3224776699

Sylvie De Rijdt, MD

Role: CONTACT

Facility Contacts

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Michel De Vos, PhD

Role: primary

+3224776699

Sylvie De Rijdt, MD

Role: backup

Other Identifiers

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Gynositol.2018

Identifier Type: -

Identifier Source: org_study_id

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