Trial Outcomes & Findings for Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success (NCT NCT02606500)
NCT ID: NCT02606500
Last Updated: 2018-11-26
Results Overview
Number of oocytes obtained in the study group was compared to the number of oocytes obtained in the control group
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
1 month
Results posted on
2018-11-26
Participant Flow
Participant milestones
| Measure |
Study Group
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.
|
Control Group
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 Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success
Baseline characteristics by cohort
| Measure |
Study Group
n=35 Participants
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.
|
Control Group
n=35 Participants
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
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
30.3 Years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
31.5 Years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
30.9 Years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Sex/Gender, Customized
Women
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Slovenia
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthNumber of oocytes obtained in the study group was compared to the number of oocytes obtained in the control group
Outcome measures
| Measure |
Study Group
n=35 Participants
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.
|
Control Group
n=35 Participants
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.
|
|---|---|---|
|
Number of Oocytes Retrieved Per Patient
|
11.3 Oocytes
Standard Deviation 7.5
|
12.4 Oocytes
Standard Deviation 7.4
|
PRIMARY outcome
Timeframe: 1 monthNumber of mature oocytes obtained was compared between groups
Outcome measures
| Measure |
Study Group
n=35 Participants
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.
|
Control Group
n=35 Participants
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.
|
|---|---|---|
|
Number of Mature Oocytes
|
269 Mature oocytes
|
319 Mature oocytes
|
PRIMARY outcome
Timeframe: 1 monthOutcome measures
| Measure |
Study Group
n=35 Participants
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.
|
Control Group
n=35 Participants
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.
|
|---|---|---|
|
Number of Fertilized Oocytes
|
206 Fertilized oocytes
|
207 Fertilized oocytes
|
PRIMARY outcome
Timeframe: 1 monthOutcome measures
| Measure |
Study Group
n=35 Participants
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.
|
Control Group
n=35 Participants
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.
|
|---|---|---|
|
Number of Frozen Embryos
|
45 Frozen embryos
|
49 Frozen embryos
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Study Group
n=35 Participants
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.
|
Control Group
n=35 Participants
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.
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|---|---|---|
|
Biochemical Pregnancy Rate
|
18 Biochemical pregnancies
|
18 Biochemical pregnancies
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Study Group
n=53 Participants
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.
|
Control Group
n=56 Participants
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.
|
|---|---|---|
|
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
Progesterone receptor (PGR)
|
2.52 Arbitrary units (Relative expression)
Standard Deviation 1.73
|
1.31 Arbitrary units (Relative expression)
Standard Deviation 0.9
|
|
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
Pentraxin 3 (PTX3)
|
1.49 Arbitrary units (Relative expression)
Standard Deviation 1.37
|
0.63 Arbitrary units (Relative expression)
Standard Deviation 0.58
|
|
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
Serpin Family E Member 2 (SERPINE2)
|
0.83 Arbitrary units (Relative expression)
Standard Deviation 0.75
|
0.61 Arbitrary units (Relative expression)
Standard Deviation 0.43
|
|
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
Follicle stimulating hormone receptor (FSHR)
|
1.29 Arbitrary units (Relative expression)
Standard Deviation 1.58
|
1.2 Arbitrary units (Relative expression)
Standard Deviation 1.15
|
|
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
Glutathione peroxidase (GPX3)
|
0.66 Arbitrary units (Relative expression)
Standard Deviation 1.31
|
0.33 Arbitrary units (Relative expression)
Standard Deviation 0.25
|
|
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
Hyaluronan Synthase 2 (HAS2)
|
1.02 Arbitrary units (Relative expression)
Standard Deviation 0.78
|
0.96 Arbitrary units (Relative expression)
Standard Deviation 0.71
|
|
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
Versican (VCAN)
|
5.40 Arbitrary units (Relative expression)
Standard Deviation 4.66
|
5.09 Arbitrary units (Relative expression)
Standard Deviation 5.6
|
|
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
Vascular endothelial growth factor C (VEGFC)
|
0.79 Arbitrary units (Relative expression)
Standard Deviation 0.46
|
0.84 Arbitrary units (Relative expression)
Standard Deviation 0.42
|
Adverse Events
Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Eda Vrtacnik Bokal
University medical centre Ljubljana
Phone: +38615226060
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place