The Effect of Clindamycin and a Live Biotherapeutic on the Reproductive Outcomes of IVF Patients With Abnormal Vaginal Microbiota
- Conditions
- Bacterial VaginosesInfertility, Female
- Interventions
- Other: Placebo
- Registration Number
- NCT05166746
- Lead Sponsor
- Peter Humaidan
- Brief Summary
Study question: Does antibiotic alone or in combination with live biotherapeutic treatment of an abnormal vaginal microbiota improve the reproductive outcomes of IVF couples?
Study hypothesis:
The investigator hypothesize that treatment of the reproductive tract pathogens and restoration of vaginal Lactobacillus will improve the reproductive outcomes of IVF patients.
What is known already? Ultra-deep sequencing methods enable the refinement of reproductive tract microbiology in infertile patients. A recent meta-analysis reported that 19% of infertile patients had abnormal vaginal microbiota Moreover, someone have detected the presence of a Gardnerella (G.) vaginalis dominated endometrial biofilm in 50% of non-infertile patients with abnormal vaginal microbiota undergoing curettage; thus the treatment of such an endometrial biofilm might play an important role for the endometrial receptivity and subsequently the clinical pregnancy rate.
Pilot study: In a recent pilot study it was observed that an abnormal vaginal microbiota negatively affects the clinical pregnancy rate in IVF patients. In this study the prevalence of abnormal vaginal microbiota was 28% (36/130) and only 9% of patients with qPCR defined abnormal vaginal microbiota obtained a clinical pregnancy (p=0.004). This association remained significant in an adjusted analysis. Furthermore, the invetigators have preliminary results demonstrating that vaginal bacteria such as G. vaginalis can be found in the endometrium of IVF patients, which is also supported by recent publications
What is the novelty of this study? To the investigators knowledge, no previous treatment study of abnormal reproductive tract microbiota has been performed in IVF patients; this relatively small intervention holds the potential to increase the baby-take-home rate after IVF treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 333
- Abnormal vaginal microbiota.
- The screening swab should be repeated if more than 3 months old.
- HIV, Hepatitis B or C positivity.
- First, second or third IVF stimulation cycle or embryo transfer therefrom.
- BMI<35
- Written informed consent.
- Known or suspected hypersensitivity to clindamycin.
- HPV CIN 2 or higher.
- Former or current inflammatory bowel disease
- Severe concomitant disease, including diabetes.
- MAX 2 embryos may be transferred
- Artificial heart valve
- Intrauterine malformations with operation indication as determined by treating physician (Polyps, Septum, fibroma)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clindamycin + placebo LACTIN-V Clindamycin Oral Clindamycin 300 mg 2 times per day for 7 days followed by LACTIN-V placebo (Osel, Inc.) until completion of the clinical pregnancy scan at week 7-9. Clindamycin + LACTIN-V (L.crispatus) Clindamycin Oral Clindamycin 300 mg 2 times per day for 7 days followed by LACTIN-V (Osel, Inc.) until completion of the clinical pregnancy scan at week 7-9. Placebo clindamycin + placebo LACTIN-V Placebo Matching clindamycin placebo 2 times per day for 7 days followed by LACTIN-V placebo (Osel Inc.) until completion of the clinical pregnancy scan at week 7-9.
- Primary Outcome Measures
Name Time Method Rate of clinical pregnancy per embryo transfer 7-9 weeks Ultrasound scan detection of intrauterine fetal heartbeat in gestational week 7-9
- Secondary Outcome Measures
Name Time Method Implantation rate pregnancy scan at 7-9 weeks The number of embryos implanting
Number of late miscarriage 12 weeks gestation - to labour (i.e. not including still birth) The of pregnancy in late pregnancy
Live birth rate 25-42 weeks depending on pregnancy. The birth of a live born child after 25 gestational weeks.
Biochemical pregnancy 14 days gestation positive hCG blood test
Cure of abnormal vaginal microbiota 1-2 months A vaginal swab and qPCR-validated diagnostics for abnormal vaginal microbiota
early miscarriage 14 days - 12 weeks gestation The loss of an hCG positive pregnancy
Number of preterm birth prior to 37 gestational weeks birth of a liveborn
Birth weight 25-42 weeks gestation depending on pregnancy weight at birth
Trial Locations
- Locations (4)
Stork Fertility Clinic VivaNeo
🇩🇰Copenhagen, Denmark
Hvidovre Hospital, The Fertility Clinic
🇩🇰Hvidovre, Denmark
Fertility Clinic Skive, Skive Regional Hospital
🇩🇰Skive, Denmark
Copenhagen University Hospital, Rigshospitalet
🇩🇰Copenhagen, Denmark