Probiotic and Antibiotic Therapies in Women With Unexplained Infertility

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2023

Primary Completion Date

January 31, 2024

Study Completion Date

December 31, 2024

Conditions
Unexplained InfertilityEndometriosis
Interventions
OTHER

SH-DS01 + Antibiotic Placebo

Participants will be instructed to take 2 capsules of SH-DS01 probiotic once daily (at lunch) from cycle day 1 to the day of ovulation/day of luteal progesterone initiation, followed by 2 capsules of SH-DS01 probiotic once daily (at lunch) and 1 capsule of placebo for antibiotic twice daily (at breakfast and dinner) from the day of ovulation/day of luteal progesterone initiation to the day of frozen embryo transfer.

DRUG

SH-DS01 + Metronidazole

Participants will be instructed to take 2 capsules of SH-DS01 probiotic once daily (at lunch) from cycle day 1 to the day of ovulation/day of luteal progesterone initiation, followed by 2 capsules of SH-DS01 probiotic once daily (at lunch) and 1 capsule of 500mg metronidazole twice daily (at breakfast and dinner) from the day of ovulation/day of luteal progesterone initiation to the day of frozen embryo transfer.

OTHER

Probiotic Placebo + Antibiotic Placebo

Participants will be instructed to take 2 capsules of placebo for probiotic once daily (at lunch) from cycle day 1 to the day of ovulation/day of luteal progesterone initiation, followed by 2 capsules of placebo for probiotic once daily (at lunch) and 1 capsule of placebo for antibiotic twice daily (at breakfast and dinner) from the day of ovulation/day of luteal progesterone initiation to the day of frozen embryo transfer.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

One Fertility

OTHER

lead

McMaster University

OTHER