Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients

• Sponsor: Universitair Ziekenhuis Brussel (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03767569
• Collaborator: (none)
• Enrollment: 134
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 7.1

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
PCOS; Female Infertility	Drug: Myo-inositol; Drug: Folic Acid	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trialRandomized controlled trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pretreatment With Myo-inositol in Hyperandrogenic PCOS Patients Undergoing ART: a Randomized Controlled Trial
• Actual Study Start Date: Sep 1, 2018
• Anticipated Primary Completion Date: Apr 1, 2020
• Anticipated Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Myo-inositol Pretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology)	Drug: Myo-inositol; Myo-inositol and Folic acid daily
Other: Folic acid Folic acid 0.4 mg daily during 12 weeks before start of ART	Drug: Folic Acid; Folic Acid daily

Outcome Measures

Primary Outcome Measures

1. Serum testosterone level after 12 weeks of administration of Myo-Inositol [2 years]

Secondary Outcome Measures

1. Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol [2 years]

2. Number of mature oocytes [2 years]

3. Embryo quality [2 years]

   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).

4. Implantation rate (%) [2 years]

5. Clinical pregnancy rate (%) [2 years]

6. Live birth rate in fresh cycle [2 years]

7. Cumulative live birth rate after 1 cycle [2 years]

8. Ovarian Hyperstimulation Syndrome rate [2 years]

9. Consumption of gonadotrophins [2 years]

   measurement in IU

10. Stimulation days [2 years]

    measurement in days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Brussel	Brussels		Belgium	1090

Sponsors and Collaborators

• Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitair Ziekenhuis Brussel
• ClinicalTrials.gov Identifier: NCT03767569
• Other Study ID Numbers: Gynositol.2018
• First Posted: Dec 6, 2018
• Last Update Posted: Dec 6, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Infertility, Female; Folic Acid; Inositol

Study Results

No Results Posted as of Dec 6, 2018