search
Back to results

Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients

Primary Purpose

PCOS, Female Infertility

Status
Unknown status
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Myo-inositol
Folic Acid
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair Ziekenhuis BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Myo-inositol

Folic acid

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol
Number of mature oocytes
Embryo quality
Day 3 embryos will be classified as transferable or cryopreservable/ 'good-quality embryos' (GQE) according to the criteria described by Van Landuyt et al. (2013). Blastocysts will be categorized according to Gardner et al. (1998) and Gardner and Schoolcraft (1999).
Implantation rate (%)
Clinical pregnancy rate (%)
Live birth rate in fresh cycle
Cumulative live birth rate after 1 cycle
Ovarian Hyperstimulation Syndrome rate
Consumption of gonadotrophins
measurement in IU
Stimulation days
measurement in days

Full Information

First Posted
April 6, 2018
Last Updated
December 5, 2018
Sponsor
Universitair Ziekenhuis Brussel
search

1. Study Identification

Unique Protocol Identification Number
NCT03767569
Brief Title
Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients
Official Title
Pretreatment With Myo-inositol in Hyperandrogenic PCOS Patients Undergoing ART: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS, Female Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myo-inositol
Arm Type
Experimental
Arm Description
Pretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology)
Arm Title
Folic acid
Arm Type
Other
Arm Description
Folic acid 0.4 mg daily during 12 weeks before start of ART
Intervention Type
Drug
Intervention Name(s)
Myo-inositol
Intervention Description
Myo-inositol and Folic acid daily
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Intervention Description
Folic Acid daily
Primary Outcome Measure Information:
Title
Serum testosterone level after 12 weeks of administration of Myo-Inositol
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol
Time Frame
2 years
Title
Number of mature oocytes
Time Frame
2 years
Title
Embryo quality
Description
Day 3 embryos will be classified as transferable or cryopreservable/ 'good-quality embryos' (GQE) according to the criteria described by Van Landuyt et al. (2013). Blastocysts will be categorized according to Gardner et al. (1998) and Gardner and Schoolcraft (1999).
Time Frame
2 years
Title
Implantation rate (%)
Time Frame
2 years
Title
Clinical pregnancy rate (%)
Time Frame
2 years
Title
Live birth rate in fresh cycle
Time Frame
2 years
Title
Cumulative live birth rate after 1 cycle
Time Frame
2 years
Title
Ovarian Hyperstimulation Syndrome rate
Time Frame
2 years
Title
Consumption of gonadotrophins
Description
measurement in IU
Time Frame
2 years
Title
Stimulation days
Description
measurement in days
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel De Vos, PhD
Phone
+3224776699
Email
michel.devos@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie De Rijdt, MD
Email
sylvie.derijdt@uzbrussel.be
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel De Vos, PhD
Phone
+3224776699
Email
michel.devos@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Sylvie De Rijdt, MD
Email
sylvie.derijdt@uzbrussel.be

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients

We'll reach out to this number within 24 hrs