Probiotic and Antibiotic Therapies in Women With Unexplained Infertility

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study is designed as a proof of concept pilot study with 3 study arms to evaluate the safety and feasibility of the use of oral probiotics and/or antibiotics in women with unexplained infertility/endometriosis. Our secondary outcomes will assess In Vitro Fertilization outcomes, and changes in the uterine microbiota (bacteria), intestinal barrier integrity, and urinary metabolites in response to study interventions.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborator: One Fertility
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Metronidazole

Criteria

Inclusion Criteria:

1. Female aged 18-40 at the time of egg retrieval

2. Generally in good health (at physician's discretion)

3. Diagnosed with Unexplained Infertility

4. Diagnosed with or suspected of having endometriosis (at ONE Fertility physician's discretion)

5. Normal uterine cavity as assessed by prior sonohysterogram

6. Planning to undergo Frozen Embryo Transfer with ≥1 frozen blastocyst ≥3BB (grade Gardner) to transfer

7. Able to understand, comply and consent to protocol requirements and instructions

8. Able to attend scheduled study visits and complete required investigations

Exclusion Criteria:

1. Any known endometrial pathologies other than endometriosis

2. Polycystic ovary syndrome

3. Ovulatory dysfunction

4. Male factor infertility (Total Motile Sperm Count <5M/mL)

5. Poorly controlled auto-immune disease and/or diabetes (at physician's discretion)

6. Is immune-compromised

7. Cockayne syndrome

8. Allergy to Metronidazole

9. Allergy to rice (bran and hull), pomegranate, Acacia gum, hypromellose, fermented gellan gum, chlorophyllin, or sunflower oil

10. Known intolerance of Lactobacillus and/or Bifidobacterium-containing probiotics

11. Antibiotic use in the past month

12. Use of any of the following:

1. Oral probiotics

2. Alcohol

3. Anticoagulant therapies (Warfarin type)

4. Drugs containing alcohol

5. Busulfan

6. Cyclosporin

7. Disulfiram

8. 5-Fluoruracil

9. Lithium

10. Phenytoin or Phenobarbital

11. Vecuronium

12. Proton pump inhibitors

13. Histamine H2-receptor antagonists

13. Currently experiencing nausea, fever, vomiting, bloody diarrhea or severe abdominal pain