Treatment of abnormal vaginal flora in patients attending in vitro fertilization treatment

Phase 1

• Conditions: Infertility; MedDRA version: 21.1Level: LLTClassification code 10021572Term: In vitro fertilizationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-002385-31-DK
• Lead Sponsor: Professor Peter Humaidan, The Fertility Clinic Skive

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-11
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 333

Inclusion Criteria

Abnormal vaginal microbiota as described above.
First, second or third IVF treatment cycle.
BMI<35.
Written informed consent.
18-42 years old
Max 2 embryos can be transferred

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 333
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

HIV, Hepatitis B or C positivity.
Known severe renal or hepatic impairment.
HPV CIN 2 or higher.
Lactose intolerans (medically diagnosed)
Patients treated with vitamin K antagonists (warfarin)
Known or suspected hypersensitivity to clindamycin
Myastenia Gravis
Intrauterine malformations
Former or current inflammatory bowel disease, including Mb. Crohn and Colitis ulcerosa
Severe concomitant disease (e.g. diabetes)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified