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The aim of the study is to study the effect of an antioxidant food supplement associated with probiotics on the oocyte quality response, oxidative stress and microbiota function in an in vitro fertilization cycle in patients with polycystic ovarian syndrome
After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will be randomized in a double-blind manner in a ratio 1:1 to receive the antioxidant supplementation associated with probiotics (Myo-Inositol, D-Chiro-Inositol, folic acid, selenium, vitamin D, Melatonin, Lactobacillus rhamnosus, Lactobacillus cripatus and Lactobacillus plantarum) or placebo (folic acid) once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FertyBiotic Woman Plus | Experimental | Participants received FertyBiotic Woman Plus one sachet a day |
|
| Placebo | Placebo Comparator | Participants received 400 mcg of folic acid once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FertyBiotic Woman Plus | Dietary Supplement | 4g Myo-Inositol, 421 mg D-Chiro-Inositol, 400 mcg folic acid, 55 mcg selenium, 15 mcg vitamin D, 1,8 mg melatonin,2x109 Lactobacillus rhamnosus, 2x109 Lactobacillus crispatus and 2x109 Lactobacillus plantarum |
| Measure | Description | Time Frame |
|---|---|---|
| Number of MII oocytes | 3 months in follicular puncture visit |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | Blood glucose | Baseline and about 2,5 months when the cycle treatment starts |
| Insulin | Blood glucose | Baseline and about 2,5 months when the cycle treatment starts |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Placebo | Other | 400 mcg folic acid |
|
| FSH | Follicle Stimulating Hormone in blood | Baseline and about 2,5 months when the cycle treatment starts |
| LH | Luteinizing Homone in blood | Baseline and about 2,5 months when the cycle treatment starts |
| Testosterone | blood testosterone | Baseline and about 2,5 months when the cycle treatment starts |
| Androstendione | blood androstendione | Baseline and about 2,5 months when the cycle treatment starts |
| MDA | Malondialdehyde (MDA) in plasma and follicular liquid | Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture) |
| TAC | Total Antioxidant Capacity (TAC) in plasma and follicular liquid | Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture) |
| 8-OH-desoxiguanosin | 8-OH-desoxiguanosin in granulose cells | 3 months in follicular puncture visit |
| Glutation | Glutation in granulose cells | 3 months in follicular puncture visit |
| Sirtuin | Sirtuin in granulose cells | 3 months in follicular puncture visit |
| Zonulin | Determination of zonulin in plasma | Baseline and about 2,5 months when the cycle treatment starts |
| SCFA | Determination of Short-Chain Fatty Acids (SCFA) in feces | Baseline and about 2,5 months when the cycle treatment starts |
| Gonadotropin UI | 3 months in follicular puncture visit |
| Follicles | Number of follicles >= 11 mm in trigger day | 3 months in follicular puncture visit |
| Stimulation days | 3 months in follicular puncture visit |
| Oocytes | Number of oocytes obtained, transferred and frozen | 3 months in follicular puncture visit |
| Pregnancy rate | Through study completion, an average of 1 year |
| Live birth rate | Through study completion, an average of 1 year |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |