Infertility, FemaleNCT04670393
Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF
A study testing FertyBiotic Woman Plus in people with Infertility, Female and Polycystic Ovary Syndrome, run by Fertypharm at 1 site in Spain.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, Female, Polycystic Ovary Syndrome
- What is being tested?
- FertyBiotic Woman Plus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2020to 23 Jan 2025
- Phase
- Interventional
- 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
- Age:18-38 years old
- Diagnosis of PCOS according to compliance with the Rotterdam criteria
- BMI >= 25
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Infertility, Female, Polycystic Ovary Syndrome
- Being tested
- FertyBiotic Woman Plus, Placebo
- Medical subject headings
- Infertility, Female, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FertyBiotic Woman PlusDietary 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
PlaceboOther
400 mcg folic acid
| Study group | Role | What they receive |
|---|---|---|
| FertyBiotic Woman Plus | Experimental | Participants received FertyBiotic Woman Plus one sachet a day Receives: Dietary Supplement: FertyBiotic Woman Plus |
| Placebo | Placebo comparator | Participants received 400 mcg of folic acid once a day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of MII oocytes
Measured: 3 months in follicular puncture visit
Secondary outcomes (19)
Glucose
Blood glucose
Measured: Baseline and about 2,5 months when the cycle treatment starts
Insulin
Blood glucose
Measured: Baseline and about 2,5 months when the cycle treatment starts
FSH
Follicle Stimulating Hormone in blood
Measured: Baseline and about 2,5 months when the cycle treatment starts
LH
Luteinizing Homone in blood
Measured: Baseline and about 2,5 months when the cycle treatment starts
Testosterone
blood testosterone
Measured: Baseline and about 2,5 months when the cycle treatment starts
Androstendione
blood androstendione
Measured: Baseline and about 2,5 months when the cycle treatment starts
MDA
Malondialdehyde (MDA) in plasma and follicular liquid
Measured: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
TAC
Total Antioxidant Capacity (TAC) in plasma and follicular liquid
Measured: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
8-OH-desoxiguanosin
8-OH-desoxiguanosin in granulose cells
Measured: 3 months in follicular puncture visit
Glutation
Glutation in granulose cells
Measured: 3 months in follicular puncture visit
Sirtuin
Sirtuin in granulose cells
Measured: 3 months in follicular puncture visit
Zonulin
Determination of zonulin in plasma
Measured: Baseline and about 2,5 months when the cycle treatment starts
SCFA
Determination of Short-Chain Fatty Acids (SCFA) in feces
Measured: Baseline and about 2,5 months when the cycle treatment starts
Gonadotropin UI
Measured: 3 months in follicular puncture visit
Follicles
Number of follicles >= 11 mm in trigger day
Measured: 3 months in follicular puncture visit
Stimulation days
Measured: 3 months in follicular puncture visit
Oocytes
Number of oocytes obtained, transferred and frozen
Measured: 3 months in follicular puncture visit
Pregnancy rate
Measured: Through study completion, an average of 1 year
Live birth rate
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 Dec 2020
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertypharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670393
- Sponsor's protocol ID
- 2020-FBM+-3
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04670393
- Acronym / sponsor ID
- 2020-FBM+-3
- Conditions
- Infertility, Female, Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- FertypharmIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 17 Dec 2020 (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 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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FertyBiotic Woman Plus | Experimental | Dietary Supplement: FertyBiotic Woman PlusParticipants received FertyBiotic Woman Plus one sachet a day |
| Placebo | Placebo comparator | Other: PlaceboParticipants received 400 mcg of folic acid once a day |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age:18-38 years old
- Diagnosis of PCOS according to compliance with the Rotterdam criteria
- BMI >= 25
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| FertyBiotic Woman Plus4g 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 | Dietary supplement | FertyBiotic Woman Plus |
| Placebo400 mcg folic acid | Other | Placebo |
Primary outcome
Number of MII oocytes
Time frame: 3 months in follicular puncture visit
19 secondary outcomes
Glucose
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Insulin
Time frame: Baseline and about 2,5 months when the cycle treatment starts
FSH
Time frame: Baseline and about 2,5 months when the cycle treatment starts
LH
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Testosterone
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Androstendione
Time frame: Baseline and about 2,5 months when the cycle treatment starts
MDA
Time frame: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
TAC
Time frame: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
8-OH-desoxiguanosin
Time frame: 3 months in follicular puncture visit
Glutation
Time frame: 3 months in follicular puncture visit
Sirtuin
Time frame: 3 months in follicular puncture visit
Zonulin
Time frame: Baseline and about 2,5 months when the cycle treatment starts
SCFA
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Gonadotropin UI
Time frame: 3 months in follicular puncture visit
Follicles
Time frame: 3 months in follicular puncture visit
Stimulation days
Time frame: 3 months in follicular puncture visit
Oocytes
Time frame: 3 months in follicular puncture visit
Pregnancy rate
Time frame: Through study completion, an average of 1 year
Live birth rate
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FertyBiotic Woman Plus in people with Infertility, Female and Polycystic Ovary Syndrome, run by Fertypharm at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 4 Dec 2025. 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 Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of MII oocytes (time frame: 3 months in follicular puncture visit). 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 4 Dec 2025.