CompletedNot Applicable

Evaluate the Use of a New Probiotic Strain in Couples With Fertility Problems and Dysbiosis.

Spain30 participantsStarted 2018-10-22

Plain-language 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 participate. The estimated duration of the study will be 7 and a half months.

Who can participate

Age range

20 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Couples with ages between 20 and 40 * Couples under an assisted reproduction treatment: Artificial Insemination or In vitro Fertilization. * Signature of informed consent Exclusion Criteria: * Anovulation * Hyperprolactinemia * Hypogonadotropic hypergonadism * Hypergonadotropic Hypergonadism * Hyperandrogenisms * Polycystic ovary syndrome * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples.

Timeframe: 7 months and a half

Trial details

NCT IDNCT03701893

SponsorProbiSearch SL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Infertility trials