Polycystic Ovary SyndromePhase 3MYOPKNCT03059173
Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome
A Phase 3 study testing Myo-Inositol + Levomefolic acid and Clomiphene Citrate in people with Polycystic Ovary Syndrome and Reproductive Medicine, run by University Hospital, Lille at 1 site in France.
Trial summary
The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double blinded. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Reproductive Medicine
- What is being tested?
- Myo-Inositol + Levomefolic acid and Clomiphene Citrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2023to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Wishing pregnancy,
- Having PCOS defined by the Rotterdam criteria: high antral follicle count (AFC) (> 19 per ovary) and/or a disorder of the cycle and/or hyperandrogenism (at least two of the three criteria),
- Having never been treated with CC (or previous treatment with CC interrupted for > 3 months).
- Having received complete information and having signed consent.
- Covered by social security
Who cannot join
- Intolerance to CC in previous treatment,
- BMI > 35,
- Other associated cause of oligoanovulation requiring specific treatment (eg., Hyperprolactinemia or functional hypothalamic anovulation),
- Ongoing pregnancy at the time of CC initiation,
- Other male or female cause of hypo-fertility,
- History of ovarian drilling,
- Negative rubella serology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Lille hôpital Jeanne de Flandre
Lille
Geoffroy Robin, MD, PhD
Geoffroy Robin, MD, PhD
About this study
Official title: Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate
The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation induction by CC. Half of them will receive MYO + levomefolic acid (5-MTHF) in addition to the CC, while the other half will receive a placebo containing only 5-MTHF in addition to the CC. The MYO supplementation will be initiated at least one month before taking CC and will be continued throughout this treatment until pregnancy or before switching to another type of treatment for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.
- Conditions
- Polycystic Ovary Syndrome, Reproductive Medicine
- Being tested
- Myo-Inositol + Levomefolic acid, Clomiphene Citrate, placebo
- Keywords
- Polycystic ovary syndrome, Reproductive medicine
- 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.
Myo-Inositol + Levomefolic acidDietary supplement
Also called Myo + [6S]-5-MethylTetrahydrofolate(5-MTHF) ou Gynositol (R)
Dietary supplement Gynositol® MTHF containing myo-inositol (4 g) and Levomefolic acid on glucosamine salts(0.736 mg) in a same bags Supplementation started on average one month before treatment with Clomiphene citrate and continued throughout cycles of Clomiphene citrate (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle.
Clomiphene CitrateDrug
Clomiphene citrate 50 mg. taking D2 to D6 of each cycle (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle and the dose will be increased if necessary.
placeboDietary supplement
a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
| Study group | Role | What they receive |
|---|---|---|
| Myo-Inositol + Levomefolic acid | Experimental | The experimental group will receive the dietary supplement: 4 g of MYO + 0.736 mg of 5-MTHF, glucosamine salts per day per os (in 2 bags per day) in addition to the standard therapy (Clomiphene Citrate). Receives: Dietary Supplement: Myo-Inositol + Levomefolic acid; Drug: Clomiphene Citrate |
| Placebo | Placebo comparator | The control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts Receives: Drug: Clomiphene Citrate; Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total resistance rate under CC for ovulation induction in patients with PCOS.
The total resistance to CC is defined by failure to ovulate at least one time during 4 subsequent cycles in women requiring 150 mg/day from D2 to D6.
Measured: At each cycle during 4 months
Secondary outcomes (4)
Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC
Measured: At each cycle during one year
Rate of drop out
Measured: at each cycle during one year
Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)
Measured: During one year
Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study
Measured: At each cycle during one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start12 Sep 2023
- Primary completion12 Sep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Laboratoires Besins International
- Responsible party
- Sponsor
- Investigators
- Goeffrey Robin, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059173
- Sponsor's protocol ID
- 2015_68
- Other IDs
- 2016-A01246-45, PHRC_N_15-0116
- Acronym
- MYOPK
- Status last verified
- Apr 2025
- First submitted
- 26 Jan 2017
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rolland AL, Peigne M, Plouvier P, Dumont A, Catteau-Jonard S, Dewailly D. Could myo-inositol soft gel capsules outperform clomiphene in inducing ovulation? Results of a pilot study. Eur Rev Med Pharmacol Sci. 2017 Jun;21(2 Suppl):10-14.
PubMed 28724178
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate
- ClinicalTrials.gov ID
- NCT03059173
- Acronym / sponsor ID
- MYOPK / 2015_68
- Conditions
- Polycystic Ovary Syndrome, Reproductive Medicine
- Keywords
- Polycystic ovary syndrome, Reproductive medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Laboratoires Besins International
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 12 Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Feb 2017 (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.
The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation induction by CC. Half of them will receive MYO + levomefolic acid (5-MTHF) in addition to the CC, while the other half will receive a placebo containing only 5-MTHF in addition to the CC. The MYO supplementation will be initiated at least one month before taking CC and will be continued throughout this treatment until pregnancy or before switching to another type of treatment for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myo-Inositol + Levomefolic acid | Experimental | Dietary Supplement: Myo-Inositol + Levomefolic acid, Drug: Clomiphene CitrateThe experimental group will receive the dietary supplement: 4 g of MYO + 0.736 mg of 5-MTHF, glucosamine salts per day per os (in 2 bags per day) in addition to the standard therapy (Clomiphene Citrate). |
| Placebo | Placebo comparator | Drug: Clomiphene Citrate, Dietary Supplement: placeboThe control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Wishing pregnancy,
- Having PCOS defined by the Rotterdam criteria: high antral follicle count (AFC) (> 19 per ovary) and/or a disorder of the cycle and/or hyperandrogenism (at least two of the three criteria),
- Having never been treated with CC (or previous treatment with CC interrupted for > 3 months).
- Having received complete information and having signed consent.
- Covered by social security
Key exclusion criteria (7 listed)
- Intolerance to CC in previous treatment,
- BMI > 35,
- Other associated cause of oligoanovulation requiring specific treatment (eg., Hyperprolactinemia or functional hypothalamic anovulation),
- Ongoing pregnancy at the time of CC initiation,
- Other male or female cause of hypo-fertility,
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-Inositol + Levomefolic acidAlso: Myo + [6S]-5-MethylTetrahydrofolate(5-MTHF) ou Gynositol (R)Dietary supplement Gynositol® MTHF containing myo-inositol (4 g) and Levomefolic acid on glucosamine salts(0.736 mg) in a same bags Supplementation started on average one month before treatment with Clomiphene citrate and continued throughout cycles of Clomiphene citrate (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle. | Dietary supplement | Myo-Inositol + Levomefolic acid |
| Clomiphene CitrateClomiphene citrate 50 mg. taking D2 to D6 of each cycle (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle and the dose will be increased if necessary. | Drug | Myo-Inositol + Levomefolic acid, Placebo |
| placeboa placebo containing only 0.736 mg of 5-MTHF, glucosamine salts | Dietary supplement | Placebo |
Primary outcome
Total resistance rate under CC for ovulation induction in patients with PCOS.
Time frame: At each cycle during 4 months
The total resistance to CC is defined by failure to ovulate at least one time during 4 subsequent cycles in women requiring 150 mg/day from D2 to D6.
4 secondary outcomes
Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC
Time frame: At each cycle during one year
Rate of drop out
Time frame: at each cycle during one year
Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)
Time frame: During one year
Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study
Time frame: At each cycle during one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 28724178Rolland AL, Peigne M, Plouvier P, Dumont A, Catteau-Jonard S, Dewailly D. Could myo-inositol soft gel capsules outperform clomiphene in inducing ovulation? Results of a pilot study. Eur Rev Med Pharmacol Sci. 2017 Jun;21(2 Suppl):10-14.
- Individual participant dataSharing planned: No
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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.
Goeffrey Robin, MD principal investigator
University Hospital, Lille
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 + Levomefolic acid and Clomiphene Citrate in people with Polycystic Ovary Syndrome and Reproductive Medicine, run by University Hospital, Lille at 1 site 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. 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 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Goeffrey ROBIN, MD (320446252 ext. +33, goeffrey.robin@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total resistance rate under CC for ovulation induction in patients with PCOS. (time frame: At each cycle during 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03059173, which also lists 1 linked publication.
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 22 Apr 2026.