Polycystic Ovary SyndromePhase 4FIV-INOPKNCT02221154
Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)
A Phase 4 study testing Inofolic® and Gonadotropins; Folic Acid in people with Polycystic Ovary Syndrome, run by Centre Hospitalier Departemental Vendee at 4 sites in France.
Trial summary
The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Inofolic® and Gonadotropins; Folic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2014to 22 May 2017
- Phase
- Phase 4
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients PCOS (Rotterdam ESHRE / ASRM criteria)
- Combination of at least two of the following three criteria:
- Cycle disorder
- Clinical hyperandrogenism and / or biological
- Account antral follicles> 24
- Age ≤ 18 ≤ 38 years
- BMI <35 kg / m²
- Able to understand the protocol and signed informed consent
Who cannot join
- Patients not having the Rotterdam criteria
- Patients> 38 years and / or BMI> 35 kg / m²
- Woman enjoying a measure of legal protection
- Hypersensitivity to any component of the Inofolic (myo-inositol, soy, folic acid, glycerol, gelatin, coloring E171)
- Participation in another interventional biomedical research with treatment administered may disrupt ovarian stimulation
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHI de Créteil
Créteil, 94000
CHD Vendée
La Roche-sur-Yon, 85925
CHU de Nantes
Nantes, 44093
CH de Saint Nazaire
Saint-Nazaire, 44606
About this study
The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients.
The aim of the study is to demonstrate that administration of myo-inositol decreases the incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS supported in IVF patients.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Inofolic®, Gonadotropins; Folic Acid
- Keywords
- in vitro fertilization, ovarian hyperstimulation, pregnancy
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inofolic®Dietary supplement
Gonadotropins; Folic AcidOther
standard ovarian stimulation
| Study group | Role | What they receive |
|---|---|---|
| Inofolic® | Experimental | standard ovarian stimulation and Inofolic® Receives: Dietary Supplement: Inofolic®; Other: Gonadotropins; Folic Acid |
| Gonadotropins;Folic Acid | Active comparator | standard ovarian stimulation without Inofolic® Receives: Other: Gonadotropins; Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startNov 2014
- Primary completion22 May 2017
- Study completion22 May 2017
Why it stopped: Difficulty recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne DELAY, PH, Principal investigator, CHD Vendée La Roche sur Yon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221154
- Sponsor's protocol ID
- CHD 096-13
- Acronym
- FIV-INOPK
- Status last verified
- Jul 2016
- First submitted
- 18 Aug 2014
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT02221154
- Acronym / sponsor ID
- FIV-INOPK / CHD 096-13
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- in vitro fertilization, ovarian hyperstimulation, pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 20 Aug 2014 (estimated)
- 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.
The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients.
The aim of the study is to demonstrate that administration of myo-inositol decreases the incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS supported in IVF patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inofolic® | Experimental | Dietary Supplement: Inofolic®, Other: Gonadotropins; Folic Acidstandard ovarian stimulation and Inofolic® |
| Gonadotropins;Folic Acid | Active comparator | Other: Gonadotropins; Folic Acidstandard ovarian stimulation without Inofolic® |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients PCOS (Rotterdam ESHRE / ASRM criteria)
- Cycle disorder
- Clinical hyperandrogenism and / or biological
- Account antral follicles> 24
- Age ≤ 18 ≤ 38 years
Key exclusion criteria (5 listed)
- Patients not having the Rotterdam criteria
- Patients> 38 years and / or BMI> 35 kg / m²
- Woman enjoying a measure of legal protection
- Hypersensitivity to any component of the Inofolic (myo-inositol, soy, folic acid, glycerol, gelatin, coloring E171)
- Participation in another interventional biomedical research with treatment administered may disrupt ovarian stimulation
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 |
|---|---|---|
| Inofolic® | Dietary supplement | Inofolic® |
| Gonadotropins; Folic Acidstandard ovarian stimulation | Other | Gonadotropins;Folic Acid, Inofolic® |
Primary outcome
Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations
Time frame: 3 month
Results and safety
The study was stopped early (reason given: Difficulty recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
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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.
Fabienne DELAY, PH principal investigator
CHD Vendée La Roche sur Yon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inofolic® and Gonadotropins; Folic Acid in people with Polycystic Ovary Syndrome, run by Centre Hospitalier Departemental Vendee at 4 sites in France.
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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations (time frame: 3 month). 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 16 Jun 2017.