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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2016-002385-31
    Trial protocol
    		 DK  
    Global end of trial date
    16 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Aug 2024
    First version publication date
    30 Aug 2024
    Other versions
    Summary report(s)
    		 RCT Manuscript

    Trial information

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    Trial identification
    Sponsor protocol code
    2015/582
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Fertility Clinic Skive, Skive regional Hopsital
    Sponsor organisation address
    Resenvej 25, Skive, Denmark, 7800
    Public contact
    Peter Humaidan, The Fertility Clinic Skive, Skive regional Hopsital, peter.humaidan@midt.rm.dk
    Scientific contact
    Peter Humaidan, The Fertility Clinic Skive, Skive regional Hopsital, peter.humaidan@midt.rm.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Aug 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Aug 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    The study was approved by the scientific Ethics Committee of the Central Denmark Region - Project ID: M-2017-157-17 Written informed consent was obtained from all participants prior to inclusion.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 338
    Worldwide total number of subjects
    338
    EEA total number of subjects
    338
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    338
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was enrolled in December 2017 and the last patient was enrolled in september 2022. Patients were recruited from four danish fertility clinics.

    Pre-assignment
    Screening details
    		 A total of 1535 patients were screened and 338 patient were randomized. However, 72 patients were not included in the modified intention to treat (mITT) analysis. This resulted in 94 CLLA, 88 CLPL, and 84 PLPL patients included in the primary mITT analysis.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active Treatment 1
    Arm description
    		 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. LACTIN-V (2 x 109 CFU/dose, 200 mg) regimen is once daily from the clindamycin stop for 7 consecutive days. If there are embryos to transfer (90%), then LACTIN-V treatment is continued twice weekly until clinical pregnancy scan, however with a maximum of 21 applicators per patient. If the patient has no embryos to transfer or is confirmed not pregnant (negative hCG test), then LACTIN-V treatment can be stopped after at least 7 days Lactin-V administration, but patients are allowed to use all 21 applicators
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clindamycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg 2 times per day for 7 days

    Investigational medicinal product name
    LACTIN-V
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for vaginal solution
    Routes of administration
    Vaginal use
    Dosage and administration details
    LACTIN-V (2 x 109 CFU/dose, 200 mg) regimen is once daily from the clindamycin stop for 7 consecutive days. If there are embryos to transfer (90%), then LACTIN-V treatment is continued twice weekly until clinical pregnancy scan, however with a maximum of 21 applicators per patient. If the patient has no embryos to transfer or is confirmed not pregnant (negative hCG test), then LACTIN-V treatment can be stopped after at least 7 days Lactin-V administration.

    Arm title
    		 Active Treatment 2
    Arm description
    		 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. The LACTIN-V placebo regimen is once daily from the clindamycin stop for 7 consecutive days. If there are embryos to transfer (90%), then Lactin-V placebo administration is continued twice weekly until clinical pregnancy scan, however with a maximum of 21 applicators per patient. If the patient has no embryos to transfer or is confirmed not pregnant, then administration of Lactin-V placebo can be stopped after at least 7 days Lactin-V placebo administration, but patients are allowed to use all 21 applicators
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clindamycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg 2 times per day for 7 days

    Arm title
    		 Inactive treatment (placebo)
    Arm description
    		 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. LACTIN-V placebo regimen is once daily from clindamycin stop and the following 7 days. If there are embryos to transfer (90%), then Lactin-V placebo administration is continued twice weekly until clinical pregnancy scan, however with a maximum of 21 applicators per patient. If the patient has no embryos to transfer or is confirmed not pregnant, then administration of live biotherapeutic placebo can be stopped after at least 7 days Lactin-V placebo administration, but patients are allowed to use all 21 applicators
    Arm type
    		 Placebo

    Investigational medicinal product name
    Clindamycin (placebo)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg 2 times per day for 7 days

    Investigational medicinal product name
    LACTIN-V (placebo)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for vaginal solution
    Routes of administration
    Vaginal use
    Dosage and administration details
    LACTIN-V (2 x 109 CFU/dose, 200 mg) regimen is once daily from the clindamycin stop for 7 consecutive days. If there are embryos to transfer (90%), then LACTIN-V treatment is continued twice weekly until clinical pregnancy scan, however with a maximum of 21 applicators per patient. If the patient has no embryos to transfer or is confirmed not pregnant (negative hCG test), then LACTIN-V treatment can be stopped after at least 7 days Lactin-V administration.

    Number of subjects in period 1 [1]
    		Active Treatment 1 Active Treatment 2 Inactive treatment (placebo)
    Started
    94
    88
    84
    Completed
    94
    88
    84
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 338 patients were randomized however, 72 patients were not included in the modified intention to treat (mITT) analysis. This resulted in a total of 266 patients.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active Treatment 1
    Reporting group description
    		 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. LACTIN-V (2 x 109 CFU/dose, 200 mg) regimen is once daily from the clindamycin stop for 7 consecutive days. If there are embryos to transfer (90%), then LACTIN-V treatment is continued twice weekly until clinical pregnancy scan, however with a maximum of 21 applicators per patient. If the patient has no embryos to transfer or is confirmed not pregnant (negative hCG test), then LACTIN-V treatment can be stopped after at least 7 days Lactin-V administration, but patients are allowed to use all 21 applicators

    Reporting group title
    Active Treatment 2
    Reporting group description
    		 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. The LACTIN-V placebo regimen is once daily from the clindamycin stop for 7 consecutive days. If there are embryos to transfer (90%), then Lactin-V placebo administration is continued twice weekly until clinical pregnancy scan, however with a maximum of 21 applicators per patient. If the patient has no embryos to transfer or is confirmed not pregnant, then administration of Lactin-V placebo can be stopped after at least 7 days Lactin-V placebo administration, but patients are allowed to use all 21 applicators

    Reporting group title
    Inactive treatment (placebo)
    Reporting group description
    		 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. LACTIN-V placebo regimen is once daily from clindamycin stop and the following 7 days. If there are embryos to transfer (90%), then Lactin-V placebo administration is continued twice weekly until clinical pregnancy scan, however with a maximum of 21 applicators per patient. If the patient has no embryos to transfer or is confirmed not pregnant, then administration of live biotherapeutic placebo can be stopped after at least 7 days Lactin-V placebo administration, but patients are allowed to use all 21 applicators

    Reporting group values
    		 Active Treatment 1 Active Treatment 2 Inactive treatment (placebo) Total
    Number of subjects
    		 94 88 84 266
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 94 88 84 266
    Age continuous
    Units: years
        median (standard deviation)
    		 31.5 ( 4.7 ) 31.8 ( 4.5 ) 31.4 ( 4.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 94 88 84 266
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Primary analysis was modified intention to treat (mITT) defined as all patients with embryo transfer less than 63 days from the active treatment start until day 1 in the embryo transfer cycle.

    Subject analysis sets values
    		 Full analysis
    Number of subjects
    266
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    266
    Age continuous
    Units: years
        median (standard deviation)
    ( )
    Gender categorical
    Units: Subjects
        Female
    266

    End points

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    End points reporting groups
    Reporting group title
    Active Treatment 1
    Reporting group description
    		 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. LACTIN-V (2 x 109 CFU/dose, 200 mg) regimen is once daily from the clindamycin stop for 7 consecutive days. If there are embryos to transfer (90%), then LACTIN-V treatment is continued twice weekly until clinical pregnancy scan, however with a maximum of 21 applicators per patient. If the patient has no embryos to transfer or is confirmed not pregnant (negative hCG test), then LACTIN-V treatment can be stopped after at least 7 days Lactin-V administration, but patients are allowed to use all 21 applicators

    Reporting group title
    Active Treatment 2
    Reporting group description
    		 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. The LACTIN-V placebo regimen is once daily from the clindamycin stop for 7 consecutive days. If there are embryos to transfer (90%), then Lactin-V placebo administration is continued twice weekly until clinical pregnancy scan, however with a maximum of 21 applicators per patient. If the patient has no embryos to transfer or is confirmed not pregnant, then administration of Lactin-V placebo can be stopped after at least 7 days Lactin-V placebo administration, but patients are allowed to use all 21 applicators

    Reporting group title
    Inactive treatment (placebo)
    Reporting group description
    		 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. LACTIN-V placebo regimen is once daily from clindamycin stop and the following 7 days. If there are embryos to transfer (90%), then Lactin-V placebo administration is continued twice weekly until clinical pregnancy scan, however with a maximum of 21 applicators per patient. If the patient has no embryos to transfer or is confirmed not pregnant, then administration of live biotherapeutic placebo can be stopped after at least 7 days Lactin-V placebo administration, but patients are allowed to use all 21 applicators

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Primary analysis was modified intention to treat (mITT) defined as all patients with embryo transfer less than 63 days from the active treatment start until day 1 in the embryo transfer cycle.

    Primary: Clinical pregnancy rate

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    End point title
    		 Clinical pregnancy rate
    End point description
    End point type
    Primary
    End point timeframe
    Gestational week 7-9
    End point values
    		 Active Treatment 1 Active Treatment 2 Inactive treatment (placebo) Full analysis
    Number of subjects analysed
    94
    88
    84
    266
    Units: Fetal heart beat
    39
    41
    38
    118
    Statistical analysis title
    		 Fisher's exact test
    Statistical analysis description
    For each treatment group CLLA, CLPL and PLPL the estimated proportions, risk ratios (RR) and their confidence intervals were calculated using uni- and multivariate logistic regression analyses by generalized linear models with log-link function. The significance level for the final analysis was set at 4.9% (95.1% confidence intervals) due to the preplanned interim analysis where an alpha of 0.1% was used.
    Comparison groups
    Active Treatment 1 v Active Treatment 2 v Inactive treatment (placebo)
    Number of subjects included in analysis
    266
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.49
    Method
    		 Fisher exact
    Parameter type
    		 Risk ratio (RR)
    Confidence interval

    Secondary: Live birth rate

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    End point title
    		 Live birth rate
    End point description
    End point type
    Secondary
    End point timeframe
    Birth
    End point values
    		 Active Treatment 1 Active Treatment 2 Inactive treatment (placebo) Full analysis
    Number of subjects analysed
    94
    88
    84
    266
    Units: Birth
    37
    40
    34
    111
    Statistical analysis title
    		 Fisher’s exact test
    Statistical analysis description
    For each treatment group CLLA, CLPL and PLPL the estimated proportions, risk ratios (RR) and their confidence intervals were calculated using uni- and multivariate logistic regression analyses by generalized linear models with log-link function. The significance level for the final analysis was set at 4.9% (95.1% confidence intervals) due to the preplanned interim analysis where an alpha of 0.1% was used.
    Comparison groups
    Active Treatment 2 v Inactive treatment (placebo) v Active Treatment 1
    Number of subjects included in analysis
    266
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.49
    Method
    		 Fisher exact
    Parameter type
    		 Risk ratio (RR)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    CLLA
    Reporting group description
    		 -

    Reporting group title
    CLPL
    Reporting group description
    		 -

    Reporting group title
    PLPL
    Reporting group description
    		 -

    Serious adverse events
    		 CLLA CLPL PLPL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 94 (3.19%)
    1 / 88 (1.14%)
    3 / 84 (3.57%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Surgical and medical procedures
    Appendicitis
         subjects affected / exposed
    3 / 94 (3.19%)
    1 / 88 (1.14%)
    3 / 84 (3.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Obs apoplexia, not confirmed
         subjects affected / exposed
    3 / 94 (3.19%)
    1 / 88 (1.14%)
    3 / 84 (3.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Arthrogryposis multiplex congenita=> late abortion
         subjects affected / exposed
    3 / 94 (3.19%)
    1 / 88 (1.14%)
    3 / 84 (3.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foetus mors
         subjects affected / exposed
    3 / 94 (3.19%)
    1 / 88 (1.14%)
    3 / 84 (3.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extrauterine pregnancy
         subjects affected / exposed
    3 / 94 (3.19%)
    1 / 88 (1.14%)
    3 / 84 (3.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Trisomi 21=> abortion
         subjects affected / exposed
    3 / 94 (3.19%)
    1 / 88 (1.14%)
    3 / 84 (3.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius hypoplasia, normal amniocentesis => live birth
         subjects affected / exposed
    3 / 94 (3.19%)
    1 / 88 (1.14%)
    3 / 84 (3.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CLLA CLPL PLPL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 94 (24.47%)
    24 / 88 (27.27%)
    22 / 84 (26.19%)
    General disorders and administration site conditions
    Nausea
         subjects affected / exposed
    8 / 94 (8.51%)
    16 / 88 (18.18%)
    17 / 84 (20.24%)
         occurrences all number
    8
    16
    17
    Fatigue
         subjects affected / exposed
    12 / 94 (12.77%)
    11 / 88 (12.50%)
    15 / 84 (17.86%)
         occurrences all number
    12
    11
    15
    Bloating
         subjects affected / exposed
    23 / 94 (24.47%)
    24 / 88 (27.27%)
    19 / 84 (22.62%)
         occurrences all number
    23
    24
    19
    Headache
         subjects affected / exposed
    4 / 94 (4.26%)
    6 / 88 (6.82%)
    7 / 84 (8.33%)
         occurrences all number
    4
    6
    7
    Urticaria
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 88 (1.14%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 94 (12.77%)
    11 / 88 (12.50%)
    15 / 84 (17.86%)
         occurrences all number
    12
    11
    15
    Reproductive system and breast disorders
    Vaginal discharge
         subjects affected / exposed
    13 / 94 (13.83%)
    14 / 88 (15.91%)
    22 / 84 (26.19%)
         occurrences all number
    13
    14
    22
    Vaginal itching
         subjects affected / exposed
    8 / 94 (8.51%)
    2 / 88 (2.27%)
    2 / 84 (2.38%)
         occurrences all number
    8
    2
    2
    Vaginal pain
         subjects affected / exposed
    2 / 94 (2.13%)
    2 / 88 (2.27%)
    2 / 84 (2.38%)
         occurrences all number
    2
    2
    2
    Vaginal smell
         subjects affected / exposed
    1 / 94 (1.06%)
    1 / 88 (1.14%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    1
    Vaginal bleeding
         subjects affected / exposed
    0 / 94 (0.00%)
    3 / 88 (3.41%)
    0 / 84 (0.00%)
         occurrences all number
    0
    3
    0
    Vaginal rash
         subjects affected / exposed
    2 / 94 (2.13%)
    1 / 88 (1.14%)
    0 / 84 (0.00%)
         occurrences all number
    2
    1
    0
    Vaginal candida
         subjects affected / exposed
    4 / 94 (4.26%)
    2 / 88 (2.27%)
    0 / 84 (0.00%)
         occurrences all number
    4
    2
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 94 (2.13%)
    1 / 88 (1.14%)
    1 / 84 (1.19%)
         occurrences all number
    2
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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