Clinical trial · Interventional
Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF
Impact of the Administration of an Antioxidant Food Supplement Associated With Oral Probiotics on the Ovarian Oxidative Stress Profile and the Intestinal Microbiota Function in the in Vitro Fertilization Cycle of Patients With Polycystic Ovarian Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility, Female | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FertyBiotic Woman Plus | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FertyBiotic Woman Plus
- description
- Participants received FertyBiotic Woman Plus one sachet a day
- interventionNames
- Dietary Supplement: FertyBiotic Woman Plus
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants received 400 mcg of folic acid once a day
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Number of MII oocytes
- timeFrame
- 3 months in follicular puncture visit
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 38 Years
Show eligibility criteria text
Inclusion Criteria: * Age:18-38 years old * Diagnosis of PCOS according to compliance with the Rotterdam criteria * BMI \>= 25 Exclusion Criteria: * Hormonal contraceptive, insulin sensitizers such as metformin, inositols, antioxidants, vitamin supplements except folic acid, GnRH analogs, steroidal drugs or others with anti-inflammatory properties, antibiotics, probiotics, laxatives use in the 3 months prior to recruitment * Tobacco consumption in last 12 months * Endometriosis, hydrosalpinx not surgically treated, acute or chronic inflammatory diseases, systemic immune diseases, other endocrine diseases or dysfunctions except for PCOS and subclinical hypothyroidism treated with low doses of levothyroxine (eg congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, Diabetes Millitus, hyperprolactinemia, hyperglycemia), active neoplastic disease or without evidence of complete remission for at least 5 years, * Active participation in an active weight reduction program or hypocaloric diet during the study period. No change in habits will be taught during the study period * Hypersensitivity to any of the components in the Fertybiotic Mujer Plus® formulation
References
Publications (0)
Data not yet available