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

Sponsor

ProbiSearch SL (Industry)

Overall Status

Completed

CT.gov ID

NCT03701893

Collaborator

(none)

Enrollment

Location

Arm

14.3

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility Vaginal Flora Imbalance Genital Disorder	Dietary Supplement: Lactobacillus PS11610	N/A

Detailed Description

Four visits are included in the study period.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open label intervention study.Open label intervention study.

Masking:

None (Open Label)

Primary Purpose:

Screening

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.

Actual Study Start Date :

Oct 22, 2018

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactobacillus PS11610 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).	Dietary Supplement: Lactobacillus PS11610 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 110E9 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 110E9 CFU of Lactobacillus PS11610 per day during 12 additional weeks.

Arm

Intervention/Treatment

Experimental: Lactobacillus PS11610

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).

Dietary Supplement: Lactobacillus PS11610

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.

Outcome Measures

Primary Outcome Measures

Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples. [7 months and a half]
The microbial composition obtained by culture of genital tracts samples from couples with infertility

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario La Paz	Madrid		Spain	28046

Sponsors and Collaborators

ProbiSearch SL

Investigators

Study Chair: Susana Manzano, PhD, ProbiSearch SL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ProbiSearch SL

ClinicalTrials.gov Identifier:

NCT03701893

Other Study ID Numbers:

FEC/18.01

First Posted:

Oct 10, 2018

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Dysbiosis

Study Results

No Results Posted as of Oct 22, 2020