InfertilityPROFECNCT03701893
Evaluate the Use of a New Probiotic Strain in Couples With Fertility Problems and Dysbiosis.
A study testing Lactobacillus PS11610 in people with Infertility and Vaginal Flora Imbalance, run by ProbiSearch SL at 1 site in Spain.
Trial summary
Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility, Vaginal Flora Imbalance, Genital Disorder
- What is being tested?
- Lactobacillus PS11610
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 22 Oct 2018to 31 Dec 2019
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Couples with ages between 20 and 40
- Couples under an assisted reproduction treatment: Artificial Insemination or In vitro Fertilization.
- Signature of informed consent
Who cannot join
- Anovulation
- Hyperprolactinemia
- Hypogonadotropic hypergonadism
- Hypergonadotropic Hypergonadism
- Hyperandrogenisms
- Polycystic ovary syndrome
Show all 19Show fewer
- Endometriosis
- Pelvic adhesions
- Myomas, polyps and / or uterine synechia
- Diagnosis of tubal factor (hydrosalpinx, tubal obstructions)
- Low ovarian reserve
- Azoospermia
- Sperm motility (A + B) <25%
- Sperm morphology ≤2%
- With chronic diseases that cause intestinal malabsorption
- With known congenital or acquired immunodeficiency.
- Obesity (IMC ≥ 30)
- Current history or diagnosis of alcohol, tobacco and drug abuse
- Uncertainty about the willingness or ability of the participants to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Effect of the Strain Lactobacillus PS11610 on the Microbiota of the Female and Male Genital Tract in Couples With Fertility Problems and Dysbiosis.
Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.
Read the detailed description
Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.
Four visits are included in the study period.
- Conditions
- Infertility, Vaginal Flora Imbalance, Genital Disorder
- Being tested
- Lactobacillus PS11610
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus PS11610Dietary supplement
7 months and a half intervention study. A 6 months intervention period preceded by a period of sampling and analysis of vaginal, seminal and gland swabs of 6 weeks. During the 6 months of intervention the men participants will intake one capsule that contains 1*10E9 colony forming unit (CFU) of Lactobacillus PS11610 and the women participating will intake two capsules of the same product (each 12 hours). If the couple stay pregnant during the intervention the man will end the product intake and the woman will reduce the dose to one capsule with 1*10E9 CFU of Lactobacillus PS11610 per day during 12 additional weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus PS11610 | Experimental | Lactobacillus PS11610 for couples with genital dysbiosis and infertility. Each dose contains 1*10E9 colony forming unit (CFU) of Lactobacillus PS11610.Two daily doses for her and one daily dose for him until pregnancy or end of study period (6 months). Receives: Dietary Supplement: Lactobacillus PS11610 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples.
The microbial composition obtained by culture of genital tracts samples from couples with infertility
Measured: 7 months and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start22 Oct 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label intervention study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProbiSearch SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susana Manzano, PhD, Study chair, ProbiSearch SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701893
- Sponsor's protocol ID
- FEC/18.01
- Acronym
- PROFEC
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effect of the Strain Lactobacillus PS11610 on the Microbiota of the Female and Male Genital Tract in Couples With Fertility Problems and Dysbiosis.
- ClinicalTrials.gov ID
- NCT03701893
- Acronym / sponsor ID
- PROFEC / FEC/18.01
- Conditions
- Infertility, Vaginal Flora Imbalance, Genital Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ProbiSearch SLIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Oct 2018 (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.
Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.
Detailed description
Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.
Four visits are included in the study period.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label intervention study.
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus PS11610 | Experimental | Dietary Supplement: Lactobacillus PS11610Lactobacillus PS11610 for couples with genital dysbiosis and infertility. Each dose contains 1*10E9 colony forming unit (CFU) of Lactobacillus PS11610.Two daily doses for her and one daily dose for him until pregnancy or end of study period (6 months). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Couples with ages between 20 and 40
- Couples under an assisted reproduction treatment: Artificial Insemination or In vitro Fertilization.
- Signature of informed consent
Key exclusion criteria (19 listed)
- Anovulation
- Hyperprolactinemia
- Hypogonadotropic hypergonadism
- Hypergonadotropic Hypergonadism
- Hyperandrogenisms
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 |
|---|---|---|
| Lactobacillus PS116107 months and a half intervention study. A 6 months intervention period preceded by a period of sampling and analysis of vaginal, seminal and gland swabs of 6 weeks. During the 6 months of intervention the men participants will intake one capsule that contains 1*10E9 colony forming unit (CFU) of Lactobacillus PS11610 and the women participating will intake two capsules of the same product (each 12 hours). If the couple stay pregnant during the intervention the man will end the product intake and the woman will reduce the dose to one capsule with 1*10E9 CFU of Lactobacillus PS11610 per day during 12 additional weeks. | Dietary supplement | Lactobacillus PS11610 |
Primary outcome
Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples.
Time frame: 7 months and a half
The microbial composition obtained by culture of genital tracts samples from couples with infertility
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 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Susana Manzano, PhD study chair
ProbiSearch SL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus PS11610 in people with Infertility and Vaginal Flora Imbalance, run by ProbiSearch SL 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 19 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 22 Oct 2020. 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. 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?
Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples. (time frame: 7 months and a half). 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 22 Oct 2020.