PCOSPhase 3NCT03767569
Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients
A Phase 3 study testing Myo-inositol and Folic Acid in people with PCOS and Female Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- PCOS, Female Infertility
- What is being tested?
- Myo-inositol and Folic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2018to Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-40 years
- PCOS phenotypes A, B and C
- Signed informed consent
Who cannot join
- Other relevant endocrine disorders
- Contraindications to the use of gonadotropins
- Endometriosis grade 3-4
- BMI > 35
Trial locations and contacts
1 site in 1 country.
Sylvie De Rijdt, MD contact
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Michel De Vos, PhD, +3224776699, michel.devos@uzbrussel.be
Sylvie De Rijdt, MD, sylvie.derijdt@uzbrussel.be
About this study
Official title: Pretreatment With Myo-inositol in Hyperandrogenic PCOS Patients Undergoing ART: a Randomized Controlled Trial
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
- Conditions
- PCOS, Female Infertility
- Being tested
- Myo-inositol, Folic Acid
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositolDrug
Myo-inositol and Folic acid daily
Folic AcidDrug
Folic Acid daily
| Study group | Role | What they receive |
|---|---|---|
| Myo-inositol | Experimental | Pretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology) Receives: Drug: Myo-inositol |
| Folic acid | Other | Folic acid 0.4 mg daily during 12 weeks before start of ART Receives: Drug: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum testosterone level after 12 weeks of administration of Myo-Inositol
Measured: 2 years
Secondary outcomes (10)
Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol
Measured: 2 years
Number of mature oocytes
Measured: 2 years
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).
Measured: 2 years
Implantation rate (%)
Measured: 2 years
Clinical pregnancy rate (%)
Measured: 2 years
Live birth rate in fresh cycle
Measured: 2 years
Cumulative live birth rate after 1 cycle
Measured: 2 years
Ovarian Hyperstimulation Syndrome rate
Measured: 2 years
Consumption of gonadotrophins
measurement in IU
Measured: 2 years
Stimulation days
measurement in days
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Sep 2018
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767569
- Sponsor's protocol ID
- Gynositol.2018
- Status last verified
- Mar 2018
- First submitted
- 6 Apr 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment With Myo-inositol in Hyperandrogenic PCOS Patients Undergoing ART: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03767569
- Acronym / sponsor ID
- Gynositol.2018
- Conditions
- PCOS, Female Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Myo-inositol | Experimental | Drug: Myo-inositolPretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology) |
| Folic acid | Other | Drug: Folic AcidFolic acid 0.4 mg daily during 12 weeks before start of ART |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-40 years
- PCOS phenotypes A, B and C
- Signed informed consent
Key exclusion criteria (4 listed)
- Other relevant endocrine disorders
- Contraindications to the use of gonadotropins
- Endometriosis grade 3-4
- BMI > 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myo-inositolMyo-inositol and Folic acid daily | Drug | Myo-inositol |
| Folic AcidFolic Acid daily | Drug | Folic acid |
Primary outcome
Serum testosterone level after 12 weeks of administration of Myo-Inositol
Time frame: 2 years
10 secondary outcomes
Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol
Time frame: 2 years
Number of mature oocytes
Time frame: 2 years
Embryo quality
Time frame: 2 years
Implantation rate (%)
Time frame: 2 years
Clinical pregnancy rate (%)
Time frame: 2 years
Live birth rate in fresh cycle
Time frame: 2 years
Cumulative live birth rate after 1 cycle
Time frame: 2 years
Ovarian Hyperstimulation Syndrome rate
Time frame: 2 years
Consumption of gonadotrophins
Time frame: 2 years
Stimulation days
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie De Rijdt, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Myo-inositol and Folic Acid in people with PCOS and Female Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel De Vos, PhD (+3224776699, michel.devos@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum testosterone level after 12 weeks of administration of Myo-Inositol (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.