Bacterial VaginosesPhase 2NCT05166746
The Effect of Clindamycin and a Live Biotherapeutic on the Reproductive Outcomes of IVF Patients With Abnormal Vaginal Microbiota
A Phase 2 study testing Clindamycin in people with Bacterial Vaginoses and Infertility, Female, run by Peter Humaidan at 4 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Bacterial Vaginoses, Infertility, Female
- What is being tested?
- Clindamycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 4 sitesDenmark
- Study dates
- 7 Dec 2017to 1 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites, 4 recruiting
- Recruiting
Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
Henriette Svarre, MD, Henriette.Svarre.Nielsen@regionh.dk
- Recruiting
Stork Fertility Clinic VivaNeo
Copenhagen, 2100
Vibeke Hartvig, MD, vibeke.hartvig@storkklinik.dk
- Recruiting
Hvidovre Hospital, The Fertility Clinic
Hvidovre, 2650
Nina La Cour Freiesleben, MD, nina.la.cour.freiesleben@regionh.dk
- Recruiting
Fertility Clinic Skive, Skive Regional Hospital
Skive, 7800
Thor Haahr, MD, thorhaahr@hotmail.com
About this study
Official title: 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
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:
Read more
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.
- Conditions
- Bacterial Vaginoses, Infertility, Female
- Being tested
- Clindamycin, Placebo
- Medical subject headings
- Vaginosis, Bacterial, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClindamycinDrug
Also called LACTIN-V
Oral clindamycin 300mg/2xdaily in 7 days. LACTIN-V applicators 1x at night in 7 days, then 2xper week at night for 7 weeks.
PlaceboOther
The Clindamycin placebo appear identical to active clindamycin by filling capsules with Mannitolium.
The LACTIN-V placebo product has no intrinsic effect and is used to study the effect of the therapeutically active product. It is supplied as a pre-filled vaginal applicator packaged under nitrogen gas with one desiccant packet (0.25 g) in a sealed foil pouch. Each applicator contains 200 mg of LACTIN-V placebo powder containing the inactive ingredients of the LACTIN-V drug product, but not Lactobacillus crispatus CTV-05 (CTV-05), the active ingedient. The excipients used in the manufacture of LACTIN-V placebo are identical to those in the LACTIN-V drug product. Each placebo applicator contains the following constituents: maltodextrin, trehalose, xylitol, colloidal silicon dioxide, and sodium ascorbate
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin + LACTIN-V (L.crispatus) | Active comparator | 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. Receives: Drug: Clindamycin |
| Clindamycin + placebo LACTIN-V | Active comparator | 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. Receives: Drug: Clindamycin |
| Placebo clindamycin + placebo LACTIN-V | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical pregnancy per embryo transfer
Ultrasound scan detection of intrauterine fetal heartbeat in gestational week 7-9
Measured: 7-9 weeks
Secondary outcomes (8)
Cure of abnormal vaginal microbiota
A vaginal swab and qPCR-validated diagnostics for abnormal vaginal microbiota
Measured: 1-2 months
Live birth rate
The birth of a live born child after 25 gestational weeks.
Measured: 25-42 weeks depending on pregnancy.
Biochemical pregnancy
positive hCG blood test
Measured: 14 days gestation
Implantation rate
The number of embryos implanting
Measured: pregnancy scan at 7-9 weeks
early miscarriage
The loss of an hCG positive pregnancy
Measured: 14 days - 12 weeks gestation
Number of late miscarriage
The of pregnancy in late pregnancy
Measured: 12 weeks gestation - to labour (i.e. not including still birth)
Number of preterm birth
birth of a liveborn
Measured: prior to 37 gestational weeks
Birth weight
weight at birth
Measured: 25-42 weeks gestation depending on pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start7 Dec 2017
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166746
- Sponsor's protocol ID
- AVM_Lacto_2015/582
- Status last verified
- Jul 2023
- First submitted
- 24 Aug 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To this date, the Danish Data Protection agency does not allow IPD to be shared. But if possible we will do so.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05166746
- Acronym / sponsor ID
- AVM_Lacto_2015/582
- Conditions
- Bacterial Vaginoses, Infertility, Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clindamycin + LACTIN-V (L.crispatus) | Active comparator | Drug: ClindamycinOral 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. |
| Clindamycin + placebo LACTIN-V | Active comparator | Drug: ClindamycinOral 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. |
| Placebo clindamycin + placebo LACTIN-V | Placebo comparator | Other: PlaceboMatching 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. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClindamycinAlso: LACTIN-VOral clindamycin 300mg/2xdaily in 7 days. LACTIN-V applicators 1x at night in 7 days, then 2xper week at night for 7 weeks. | Drug | Clindamycin + LACTIN-V (L.crispatus), Clindamycin + placebo LACTIN-V |
| PlaceboThe Clindamycin placebo appear identical to active clindamycin by filling capsules with Mannitolium. The LACTIN-V placebo product has no intrinsic effect and is used to study the effect of the therapeutically active product. It is supplied as a pre-filled vaginal applicator packaged under nitrogen gas with one desiccant packet (0.25 g) in a sealed foil pouch. Each applicator contains 200 mg of LACTIN-V placebo powder containing the inactive ingredients of the LACTIN-V drug product, but not Lactobacillus crispatus CTV-05 (CTV-05), the active ingedient. The excipients used in the manufacture of LACTIN-V placebo are identical to those in the LACTIN-V drug product. Each placebo applicator contains the following constituents: maltodextrin, trehalose, xylitol, colloidal silicon dioxide, and sodium ascorbate | Other | Placebo clindamycin + placebo LACTIN-V |
Primary outcome
Rate of clinical pregnancy per embryo transfer
Time frame: 7-9 weeks
Ultrasound scan detection of intrauterine fetal heartbeat in gestational week 7-9
8 secondary outcomes
Cure of abnormal vaginal microbiota
Time frame: 1-2 months
Live birth rate
Time frame: 25-42 weeks depending on pregnancy.
Biochemical pregnancy
Time frame: 14 days gestation
Implantation rate
Time frame: pregnancy scan at 7-9 weeks
early miscarriage
Time frame: 14 days - 12 weeks gestation
Number of late miscarriage
Time frame: 12 weeks gestation - to labour (i.e. not including still birth)
Number of preterm birth
Time frame: prior to 37 gestational weeks
Birth weight
Time frame: 25-42 weeks gestation depending on pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: Undecided. To this date, the Danish Data Protection agency does not allow IPD to be shared. But if possible we will do so.
Related trials for Bacterial Vaginoses
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clindamycin in people with Bacterial Vaginoses and Infertility, Female, run by Peter Humaidan at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thor Haahr, MD (+4527885402, thohaa@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinical pregnancy per embryo transfer (time frame: 7-9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.