Back to resultsEvaluate the Use of a New Probiotic Strain in Couples With Fertility Problems and Dysbiosis. (PROFEC)
Primary Purpose
Infertility, Vaginal Flora Imbalance, Genital Disorder
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lactobacillus PS11610
Sponsored by
About this trial
This is an interventional screening trial for Infertility
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario La Paz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lactobacillus PS11610
Arm Description
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).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03701893
Brief Title
Evaluate the Use of a New Probiotic Strain in Couples With Fertility Problems and Dysbiosis.
Acronym
PROFEC
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProbiSearch SL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Vaginal Flora Imbalance, Genital Disorder
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label intervention study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactobacillus PS11610
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus PS11610
Intervention Description
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.
Primary Outcome Measure Information:
Title
Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples.
Description
The microbial composition obtained by culture of genital tracts samples from couples with infertility
Time Frame
7 months and a half
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana Manzano, PhD
Organizational Affiliation
ProbiSearch SL
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluate the Use of a New Probiotic Strain in Couples With Fertility Problems and Dysbiosis.
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