Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01246-45 | Other Identifier | ID-RCB number, ANSM | |
| PHRC_N_15-0116 | Other Identifier | PHRC number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Laboratoires Besins International | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myo-Inositol + Levomefolic acid | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At each cycle during 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC | At each cycle during one year | |
| Rate of drop out | at each cycle during one year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Woman of childbearing age
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Goeffrey ROBIN, MD | Contact | 320446252 | +33 | goeffrey.robin@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Goeffrey Robin, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille hôpital Jeanne de Flandre | Recruiting | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28724178 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
Not provided
Not provided
| ID | Term |
|---|---|
| D007294 | Inositol |
| C005984 | 5-methyltetrahydrofolate |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Clomiphene Citrate | Drug | 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. |
|
| placebo | Dietary Supplement | a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts |
|
| Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea) | During one year |
| Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study | At each cycle during one year |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D013267 |
| Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |