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    Clinical Trial Results:
    RIOT C: REDUCING THE IMPACT OF OVARIAN STIMULATION. NOVEL APPROACHES TO LUTEAL SUPPORT IN IVF. STUDY 2.

    Summary
    EudraCT number
    		 2017-004433-93
    Trial protocol
    		 DK  
    Global end of trial date
    30 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2021
    First version publication date
    22 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RIOTCSTUDY22017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Nicholas Stephan Macklon, Region Zealand Fertility Clinic
    Sponsor organisation address
    Lykkebækvej 14, Køge, Denmark, 4600
    Public contact
    Unit of Reproductive Medicine, Nichohlas Stephen Macklon, Professor, MD, PhD. Unit of Reproductive Medicine, 45 53621645, nick.macklon@londonwomensclinic.com
    Scientific contact
    Unit of Reproductive Medicine, Nichohlas Stephen Macklon, Professor, MD, PhD. Unit of Reproductive Medicine, 45 47324007, nism@regionsjaelland.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
    01 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The goal of the trial is to determine wheather co-treatment with aromatase inhibitor in ovarian stimulation in egg donors normalize the duartion of the unsupported luteal phase, reduce the endometrium thickness, positively modulate endocrine markers of luteal phase quality and endometrial markers of receptivity.
    Protection of trial subjects
    Participants were withdrawn from the study if they suffered from serious adverse events or reactions during OS including severe allergy to study drug or withdraw consent. In case of severe degree of hot flushes, severe degree of nausea/vomiting, severe diarrhea or severe degree of muscle and joint pain the participant were also excluded.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    25
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Egg donors were invited to participate in this study at their first visit in the Fertility clinic or at the day of starting up ovarian stimulation. Before inclusion the paticipant received verbal and written information about the study and signed a consent form.

    Pre-assignment
    Screening details
    		 The inclusion criteria included acceptance as an oocyte donor according to local criteria, age ≤35 years and regular ovulatory cycle of 26-32 days. Exclusion criteria were polycystic ovary syndrome, known allergy to letrozole or an intrauterine device (within the last three months from inclusion).

    Pre-assignment period milestones
    Number of subjects started
    		 25
    Number of subjects completed
    		 25

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Letrozole group
    Arm description
    		 Adjuvant letrozole 5,0 mg/day from stimulation day 1 and throughout ovarian stimulation with a flexible dose of rFSH i an antagonist protocol
    Arm type
    		 Letrozole group

    Investigational medicinal product name
    Letrozole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg per day from ovarian stimulation day 1 and throughout stimulation

    Arm title
    		 Control group
    Arm description
    		 Standard ovarian stimulation with a flexible dose of rFSH in an antagonist protocol
    Arm type
    		 Control group

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Letrozole group Control group
    Started
    11
    14
    Completed
    10
    12
    Not completed
    1
    2
         Consent withdrawn by subject
    -
    1
         Cycle cancellation
    1
    -
         Lack of compliance
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Letrozole group
    Reporting group description
    		 Adjuvant letrozole 5,0 mg/day from stimulation day 1 and throughout ovarian stimulation with a flexible dose of rFSH i an antagonist protocol

    Reporting group title
    Control group
    Reporting group description
    		 Standard ovarian stimulation with a flexible dose of rFSH in an antagonist protocol

    Reporting group values
    		 Letrozole group Control group Total
    Number of subjects
    		 11 14 25
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 11 14 25
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 29.0 (25.3 to 31.0) 30.5 (25.0 to 31.0) -
    Gender categorical
    Units: Subjects
        Female
    		 11 14 25
        Male
    		 0 0 0
    AMH
    Anti-Müllerian hormone
    Units: pmol/L
        median (inter-quartile range (Q1-Q3))
    		 19.5 (16.0 to 40.9) 18.0 (8.5 to 34.1) -
    Cycle duration
    Days of menstrual cycle
    Units: Days
        median (inter-quartile range (Q1-Q3))
    		 28.0 (28.0 to 29.25) 28.0 (28.0 to 29.8) -
    BMI
    Body Mass Index
    Units: kg/m2
        median (inter-quartile range (Q1-Q3))
    		 25.3 (22.0 to 27.9) 25.2 (22.3 to 29.4) -

    End points

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    End points reporting groups
    Reporting group title
    Letrozole group
    Reporting group description
    		 Adjuvant letrozole 5,0 mg/day from stimulation day 1 and throughout ovarian stimulation with a flexible dose of rFSH i an antagonist protocol

    Reporting group title
    Control group
    Reporting group description
    		 Standard ovarian stimulation with a flexible dose of rFSH in an antagonist protocol

    Primary: Duration of luteal phase

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    End point title
    		 Duration of luteal phase
    End point description
    End point type
    Primary
    End point timeframe
    From oocyte aspiration and 14 days ahead.
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10 [1]
    12 [2]
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Increase of duration of luteal phase
    8.0 (6.8 to 11.5)
    5.0 (5.0 to 6.8)
    Notes
    [1] - One participant was excluded
    [2] - Two participants were excluded
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Secondary: Estradiol OPU

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    End point title
    		 Estradiol OPU
    End point description
    End point type
    Secondary
    End point timeframe
    At oocyte pick up (OPU)
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    12
    Units: nmol/L
    median (inter-quartile range (Q1-Q3))
        Reduction in estradiol
    0.9 (0.2 to 1.2)
    2.8 (1.3 to 3.4)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.004
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Progesterone OPU

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    End point title
    		 Progesterone OPU
    End point description
    End point type
    Secondary
    End point timeframe
    At oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    12
    Units: nmol/L
        median (inter-quartile range (Q1-Q3))
    25.9 (15.2 to 39.2)
    21.6 (12.8 to 36.2)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.628
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: LH OPU

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    End point title
    		 LH OPU
    End point description
    End point type
    Secondary
    End point timeframe
    At oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    12
    Units: IU/L
        median (inter-quartile range (Q1-Q3))
    6.4 (6.4 to 10.8)
    3.0 (2.6 to 5.1)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: FSH OPU

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    End point title
    		 FSH OPU
    End point description
    End point type
    Secondary
    End point timeframe
    At oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    12
    Units: IU/L
        median (inter-quartile range (Q1-Q3))
    9.4 (8.1 to 11.7)
    8.1 (6.7 to 9.9)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.203
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Endometrial thickness OPU

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    End point title
    		 Endometrial thickness OPU
    End point description
    End point type
    Secondary
    End point timeframe
    At oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    12
    Units: mm
        median (inter-quartile range (Q1-Q3))
    9.9 (6.7 to 11.3)
    9.7 (8.1 to 13.1)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.582
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Estradiol OPU+2

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    End point title
    		 Estradiol OPU+2
    End point description
    End point type
    Secondary
    End point timeframe
    Two days after Oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    12
    Units: nmol/L
        median (inter-quartile range (Q1-Q3))
    0.2 (0.1 to 0.3)
    1.6 (1.1 to 3.2)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Endometrial thickness OPU+5

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    End point title
    		 Endometrial thickness OPU+5
    End point description
    End point type
    Secondary
    End point timeframe
    Five days after ovarian stimulation
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    9
    9
    Units: nmol/L
        median (inter-quartile range (Q1-Q3))
    6.0 (4.3 to 8.1)
    5.7 (4.0 to 7.7)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Control group v Letrozole group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.72
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Estradiol OPU+5

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    End point title
    		 Estradiol OPU+5
    End point description
    End point type
    Secondary
    End point timeframe
    Five days after oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    11
    Units: nmol/L
        median (inter-quartile range (Q1-Q3))
    0.2 (0.2 to 0.2)
    0.3 (0.2 to 0.4)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Estradiol OPU+14

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    End point title
    		 Estradiol OPU+14
    End point description
    End point type
    Secondary
    End point timeframe
    14 days after oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    10
    Units: nmol/L
        median (inter-quartile range (Q1-Q3))
    0.1 (0.1 to 0.2)
    0.2 (0.1 to 0.2)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.436
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Progesterone OPU+2

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    End point title
    		 Progesterone OPU+2
    End point description
    End point type
    Secondary
    End point timeframe
    Two days after oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    12
    Units: nmol/L
        median (inter-quartile range (Q1-Q3))
    76.1 (57.0 to 126.3)
    32.9 (17.4 to 52.8)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Progesterone OPU+5

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    End point title
    		 Progesterone OPU+5
    End point description
    End point type
    Secondary
    End point timeframe
    Five days after oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    11
    Units: nmol/L
        median (inter-quartile range (Q1-Q3))
    67.1 (15.7 to 101.8)
    2.3 (1.1 to 10.7)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Progesterone OPU+14

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    End point title
    		 Progesterone OPU+14
    End point description
    End point type
    Secondary
    End point timeframe
    14 days after oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    10
    Units: nmol/L
        median (inter-quartile range (Q1-Q3))
    0.8 (0.3 to 2.1)
    0.3 (0.3 to 0.4)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Control group v Letrozole group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.089
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: LH OPU+2

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    End point title
    		 LH OPU+2
    End point description
    End point type
    Secondary
    End point timeframe
    Two days after oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    12
    Units: IU/L
        median (inter-quartile range (Q1-Q3))
    1.8 (1.4 to 2.4)
    1.2 (0.5 to 1.5)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: LH OPU+5

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    End point title
    		 LH OPU+5
    End point description
    End point type
    Secondary
    End point timeframe
    Five days after oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    11
    Units: IU/L
        median (inter-quartile range (Q1-Q3))
    1.6 (1.3 to 3.0)
    1.8 (1.2 to 2.5)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Control group v Letrozole group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.654
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: LH OPU+14

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    End point title
    		 LH OPU+14
    End point description
    End point type
    Secondary
    End point timeframe
    14 days after oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    10
    Units: IU/L
        median (inter-quartile range (Q1-Q3))
    4.9 (3.4 to 6.0)
    5.8 (3.3 to 8.5)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.393
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: FSH OPU+2

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    End point title
    		 FSH OPU+2
    End point description
    End point type
    Secondary
    End point timeframe
    Two days after oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    12
    Units: IU/L
        median (inter-quartile range (Q1-Q3))
    4.1 (3.4 to 5.7)
    3.9 (2.4 to 4.8)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.456
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: FSH OPU+5

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    End point title
    		 FSH OPU+5
    End point description
    End point type
    Secondary
    End point timeframe
    Five days after oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    11
    Units: IU/L
        median (inter-quartile range (Q1-Q3))
    3.9 (1.8 to 4.8)
    2.0 (0.5 to 3.5)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.132
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: FSH OPU+14

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    End point title
    		 FSH OPU+14
    End point description
    End point type
    Secondary
    End point timeframe
    14 days after oocyte retrieval
    End point values
    		 Letrozole group Control group
    Number of subjects analysed
    10
    12
    Units: IU/L
        median (inter-quartile range (Q1-Q3))
    6.4 (6.0 to 7.9)
    6.2 (4.5 to 8.7)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Letrozole group v Control group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.739
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From start of stimulation to 14 days after oocyte aspiration
    Adverse event reporting additional description
    Only serious adverse events OR rections as well as NOT KNOWN reactions/events were reported
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 No
    Dictionary version
    0
    Reporting groups
    Reporting group title
    All adverse events
    Reporting group description
    		 All adverse events

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: In this study ONLY Serious adverse events/reactions OR not known events/reactions were recorded.
    Serious adverse events
    		 All adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Abdominal pain
    Additional description: One participant in the control group was admitted to the hospital overnight for observation because of abdominal pain after oocyte aspiration
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Dec 2019
    1. Co-investigator added 2. Extension of study, changed to November 30th 2020 3. Inclusion criteria: Duration of menstruation cycle changed to 26 to 32 days from 26 to 28 days. 4. Flexible dose of FSH in stead of fixed dose 5. Endometrial fluid aspiration removed from protocol 6. Ultrasound examination two days after oocyte retrieval removed

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    09 Mar 2020
    Due to the Covid-19 pandemic the Fertility clinics were closed down in this period of time
    04 May 2020

    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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