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Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success

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ClinicalTrials.gov Identifier: NCT02606500
Recruitment Status : Completed
First Posted : November 17, 2015
Results First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Tanja Burnik Papler, University Medical Centre Ljubljana

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity
Intervention Drug: Elonva
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Group Control Group
Hide Arm/Group Description

35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram.

35 normal weighing women (BMI 19 – 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 – 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram.

Period Title: Overall Study
Started 35 35
Completed 35 35
Not Completed 0 0
Arm/Group Title Study Group Control Group Total
Hide Arm/Group Description

35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram.

35 normal weighing women (BMI 19 – 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 – 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram.

s.

Total of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 35 participants 35 participants 70 participants
30.3  (3.9) 31.5  (3.6) 30.9  (3.7)
Sex/Gender, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Women Number Analyzed 35 participants 35 participants 70 participants
35
 100.0%
35
 100.0%
70
 100.0%
[1]
Measure Description: Only women were included in the study.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
35
 100.0%
35
 100.0%
70
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Slovenia Number Analyzed 35 participants 35 participants 70 participants
35
 100.0%
35
 100.0%
70
 100.0%
1.Primary Outcome
Title Number of Oocytes Retrieved Per Patient
Hide Description Number of oocytes obtained in the study group was compared to the number of oocytes obtained in the control group
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:

35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram.

35 normal weighing women (BMI 19 – 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 – 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram.

Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: Oocytes
11.3  (7.5) 12.4  (7.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
2.Primary Outcome
Title Number of Mature Oocytes
Hide Description Number of mature oocytes obtained was compared between groups
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:

35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram.

35 normal weighing women (BMI 19 – 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 – 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram.

Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: Mature oocytes
269 319
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
3.Primary Outcome
Title Number of Fertilized Oocytes
Hide Description [Not Specified]
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:

35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram.

35 normal weighing women (BMI 19 – 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 – 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram.

Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: Fertilized oocytes
206 207
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
4.Primary Outcome
Title Number of Frozen Embryos
Hide Description [Not Specified]
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:

35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram.

35 normal weighing women (BMI 19 – 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 – 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram.

Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: Frozen embryos
45 49
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
5.Primary Outcome
Title Biochemical Pregnancy Rate
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:

35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram.

35 normal weighing women (BMI 19 – 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 – 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram.

Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: Biochemical pregnancies
18 18
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments We presumed Elonva 150 mcg in obese and normal weighing women yields comparable biochemical pregnancy rates.
Statistical Test of Hypothesis P-Value 0.4
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
6.Secondary Outcome
Title Real-time PCR Analysis of Genes That Were Proposed as Biomarkers of Oocyte Quality to Determine Effect of Corifollitropin Alpha on Oocyte Quality on Molecular Level
Hide Description Expression of some genes that were proposed as biomarkers of oocyte quality was analysed in CC using real-time PCR. Relative expression values of genes were compared between mature oocytes derived from obese women and mature oocytes derived from normal weighing women.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Gene expression in cumulus cells surrounding mature oocytes was analyzed using quantitative polymerase chain reaction (qPCR). We analyzed 53 CC samples in the Study group and 56 CC samples in Control group.
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:

35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram.

35 normal weighing women (BMI 19 – 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 – 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram.

Overall Number of Participants Analyzed 53 56
Mean (Standard Deviation)
Unit of Measure: Arbitrary units (Relative expression)
Progesterone receptor (PGR) 2.52  (1.73) 1.31  (0.9)
Pentraxin 3 (PTX3) 1.49  (1.37) 0.63  (0.58)
Serpin Family E Member 2 (SERPINE2) 0.83  (0.75) 0.61  (0.43)
Follicle stimulating hormone receptor (FSHR) 1.29  (1.58) 1.2  (1.15)
Glutathione peroxidase (GPX3) 0.66  (1.31) 0.33  (0.25)
Hyaluronan Synthase 2 (HAS2) 1.02  (0.78) 0.96  (0.71)
Versican (VCAN) 5.40  (4.66) 5.09  (5.6)
Vascular endothelial growth factor C (VEGFC) 0.79  (0.46) 0.84  (0.42)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group Control Group
Hide Arm/Group Description

35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram.

35 normal weighing women (BMI 19 – 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR.

Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 – 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram.

All-Cause Mortality
Study Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Study Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Eda Vrtacnik Bokal
Organization: University medical centre Ljubljana
Phone: +38615226060
EMail: eda.bokal@guest.arnes.si
Layout table for additonal information
Responsible Party: Tanja Burnik Papler, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02606500     History of Changes
Other Study ID Numbers: Merck-01
First Submitted: November 6, 2015
First Posted: November 17, 2015
Results First Submitted: August 30, 2017
Results First Posted: November 26, 2018
Last Update Posted: November 26, 2018