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

A double-blind, placebo-controlled multicenter trial on the effect of clindamycin and a live biotherapeutic on the reproductive outcomes of IVF patients with abnormal vaginal microbiota

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002385-31-DK

Enrollment

333

Registered

2016-07-11

Start date

2017-08-28

Completion date

Unknown

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility MedDRA version: 21.1 Level: LLT Classification code 10021572 Term: In vitro fertilization System Organ Class: 100000004865

Interventions

Trade Name: Clindamycin "Alternova" Product Name: Clindamycin "Alternova" Product Code: 37826 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Clindamycin "Alternova" Other descriptive name: CL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Abnormal vaginal microbiota as described above. First, second or third IVF treatment cycle. BMI=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the present trial is to investigate the effect of antibiotic and probiotic treatment on the reproductive outcome of IVF patients with abnormal vaginal microbiota (AVM). The aim is to investigate whether treatment of AVM improve the success-rate of IVF patients.;Secondary Objective: The microbiome of women attending IVF treatment;Primary end point(s): Primary outcome: Clinical pregnancy rate (Ultrasound proven fetal heartbeat week 7). Key secondary outcome: Live birth rate. Secondary outcomes: Biochemical pregnancy rate (hCG at day 14), implantation rate, early miscarriage, late miscarriage, and preterm birth rates, adverse effects of the medication. Furthermore, the effect of treatment on the vaginal microbiota of the mother throughout pregnancy will be determined with next generation sequencing. ;Timepoint(s) of evaluation of this end point: Clinical pregnancy scan, Live birth etc.	—

Measure

Time frame

Main Objective: The aim of the present trial is to investigate the effect of antibiotic and probiotic treatment on the reproductive outcome of IVF patients with abnormal vaginal microbiota (AVM). The aim is to investigate whether treatment of AVM improve the success-rate of IVF patients.;Secondary Objective: The microbiome of women attending IVF treatment;Primary end point(s): Primary outcome: Clinical pregnancy rate (Ultrasound proven fetal heartbeat week 7). Key secondary outcome: Live birth rate. Secondary outcomes: Biochemical pregnancy rate (hCG at day 14), implantation rate, early miscarriage, late miscarriage, and preterm birth rates, adverse effects of the medication. Furthermore, the effect of treatment on the vaginal microbiota of the mother throughout pregnancy will be determined with next generation sequencing. ;Timepoint(s) of evaluation of this end point: Clinical pregnancy scan, Live birth etc.

—

Secondary

Measure	Time frame
Secondary end point(s): microbiome of longitudinal samples;Timepoint(s) of evaluation of this end point: end of study	—

Countries

Denmark

Contacts

Public ContactAlice Toft Mikkelsen

The Fertility Clinic Skive, Skive regional Hopsital

alice.toft.mikkelsen@midt.rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 17, 2026