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Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

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ClinicalTrials.gov Identifier: NCT03088137
Recruitment Status : Completed
First Posted : March 23, 2017
Results First Posted : June 6, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
BridgePharm LLC
GlobalPharma LLC
Information provided by (Responsible Party):
IVFarma LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Infertility, Female
Interventions Drug: Follitropin alfa (Gonal-f)
Drug: Follitropin alfa (Primapur)
Enrollment 118
Recruitment Details Subjects were screened and enrolled at 3 In Vitro Fertilisation (IVF) centers in Russian Federation from 08.02.2017 - 17.08.2018.
Pre-assignment Details Of 118 participants: 8 were reported as screening failures prior the group assignment.
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description Follitropin alfa (Primapur): Subcutaneous injection (pen-injector), fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation Follitropin alfa (Gonal-f): Subcutaneous injection (pen-injector), fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Period Title: Overall Study
Started 55 55
Completed 55 55
Not Completed 0 0
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa) Total
Hide Arm/Group Description Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation Total of all reporting groups
Overall Number of Baseline Participants 55 55 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 55 participants 110 participants
31.3  (2.68) 30.0  (2.71) 30.65  (2.75)
[1]
Measure Description: Mean (Standard Deviation)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
Female
55
 100.0%
55
 100.0%
110
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 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
55
 100.0%
55
 100.0%
110
 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: Number
Unit of measure:  Participants
Russia Number Analyzed 55 participants 55 participants 110 participants
55 55 110
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 55 participants 55 participants 110 participants
22.0  (2.69) 22.3  (3.06) 22.15  (2.87)
[1]
Measure Description: kg/m2
Duration of infertility   [1] 
Mean (Standard Deviation)
Unit of measure:  Month
Number Analyzed 55 participants 55 participants 110 participants
46.4  (32.4) 36.9  (26.6) 41.65  (28.22)
[1]
Measure Description: month
Antral follicle   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of antral follicles
Number Analyzed 55 participants 55 participants 110 participants
11.2  (3.2) 12.4  (2.4) 11.80  (2.87)
[1]
Measure Description: Mean (Standard Deviation)
Anti-mullerian hormone (AMH)   [1] 
Mean (Standard Deviation)
Unit of measure:  Ng per ml
Number Analyzed 55 participants 55 participants 110 participants
4.57  (2.96) 5.47  (3.82) 5.02  (3.43)
[1]
Measure Description: Mean (Standard deviation)
Follicle stimulating hormone (FSH)   [1] 
Mean (Standard Deviation)
Unit of measure:  IU/l
Number Analyzed 55 participants 55 participants 110 participants
6.46  (1.86) 6.76  (1.89) 6.61  (1.87)
[1]
Measure Description: IU per l
Estradiol  
Mean (Standard Deviation)
Unit of measure:  Pg/ml
Number Analyzed 55 participants 55 participants 110 participants
35.87  (12.67) 33.82  (12.45) 34.85  (12.54)
Cause of infertility   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
Tubal factor
21
  38.2%
18
  32.7%
39
  35.5%
Male factor
21
  38.2%
27
  49.1%
48
  43.6%
Tubal and male factors
13
  23.6%
10
  18.2%
23
  20.9%
[1]
Measure Description: Patients with the determined cause of infertility
1.Primary Outcome
Title Oocytes (Intention-to-Treat, ITT)
Hide Description The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes.
Time Frame From date of randomization up to 18 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: Number of retrieved oocytes
12.16  (7.28) 11.62  (6.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Study power of at least 80% at a significance level (alpha error) 5% and a pre-determined clinical equivalence margin of +/- 3.4 oocytes for the relevant population.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.546
Confidence Interval (2-Sided) 95%
-2.026 to 3.116
Parameter Dispersion
Type: Standard Deviation
Value: 1.297
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Follicles With Size ≥ 16 mm
Hide Description The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration
Time Frame From date of randomization up to 16 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: Number of follicles
12.09  (6.159) 11.38  (4.965)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.806
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.709
Confidence Interval (2-Sided) 95%
-1.405 to 2.824
Parameter Dispersion
Type: Standard Deviation
Value: 1.067
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mature Oocytes
Hide Description The number of mature oocytes (MII stage of development)
Time Frame From date of randomization up to 18 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: Number of mature oocytes (MII stage)
9.64  (6.270) 9.86  (5.546)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.617
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.218
Confidence Interval (2-Sided) 95%
-2.455 to 2.019
Parameter Dispersion
Type: Standard Deviation
Value: 1.129
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Fertilised Oocytes
Hide Description The number of fertilised oocytes with the presence of two pronuclei: 2PN
Time Frame From date of randomization up to 19 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: Number of oocytes with 2PN
8.127  (6.608) 8.764  (5.850)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.445
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.636
Confidence Interval (2-Sided) 95%
-2.995 to 1.723
Parameter Dispersion
Type: Standard Deviation
Value: 1.190
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Patients With Embryo Transfer
Hide Description The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up
Time Frame From date of randomization up to 25 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 49 49
Measure Type: Count of Participants
Unit of Measure: Participants
Embryo transfer on day 3 (%)
11
  22.4%
9
  18.4%
Embryo transfer on day 5 (%)
38
  77.6%
40
  81.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.623
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Total Dose of Follitropin Alfa
Hide Description The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU)
Time Frame From date of randomization up to 16 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: Total dose (IU)
1532.7  (267.2) 1517.9  (255.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.488
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.9
Confidence Interval (2-Sided) 95%
-83.9 to 113.6
Parameter Dispersion
Type: Standard Deviation
Value: 49.8
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Days of Follitropin Alfa Treatment
Hide Description The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation)
Time Frame From date of randomization up to 16 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: Days
9.745  (1.075) 9.727  (1.027)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.629
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.018
Confidence Interval (2-Sided) 95%
-0.379 to 0.416
Parameter Dispersion
Type: Standard Deviation
Value: 0.201
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Patients With Follitropin Alfa Dose Correction
Hide Description The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU)
Time Frame From date of randomization up to 16 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
13
  23.6%
11
  20.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.644
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Number of Patients With Cycle Cancellation
Hide Description The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation)
Time Frame From date of randomization up to 16 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of No-responders
Hide Description The number of patients with no response to follitropin alfa treatment (absence of growing follicles, no any oocytes obtained at the day of ovum pick-up)
Time Frame From date of randomization up to 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Percentage of Patients With Serum hCG More Than 25 IU/l
Hide Description Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer)
Time Frame From date of randomization up to 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 49 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients (%)
34.7
(21.4 to 48.0)
36.7
(23.2 to 50.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
Comments 95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.833
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-21.0 to 17.0
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Patients With the Evidence for Clinical Pregnancy
Hide Description Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity
Time Frame The 10th week after embryo transfer
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description:
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Overall Number of Participants Analyzed 49 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients (%)
26.5
(14.1 to 38.9)
32.7
(19.6 to 45.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
Comments 95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.507
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-24.3 to 11.9
Estimation Comments [Not Specified]
Time Frame 1 year, 6 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Hide Arm/Group Description Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
All-Cause Mortality
Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)      0/55 (0.00%)    
Hide Serious Adverse Events
Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/55 (3.64%)      2/55 (3.64%)    
Injury, poisoning and procedural complications     
Iatrogenic injury  1 [1]  1/55 (1.82%)  1 0/55 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Threatened miscarriage  1  1/55 (1.82%)  1 0/55 (0.00%)  0
Reproductive system and breast disorders     
Ovarian hyperstymulation syndrome  1 [2]  0/55 (0.00%)  0 2/55 (3.64%)  2
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
[1]
iatrogenic bladder injury during transvaginal ovarian puncturing
[2]
Patients with positive pregnancy test
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Primapur (Follitropin Alfa) Gonal-f (Follitropin Alfa)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/55 (38.18%)      13/55 (23.64%)    
Cardiac disorders     
Sternum pain  1  1/55 (1.82%)  1 0/55 (0.00%)  0
Palpitations  1  1/55 (1.82%)  1 0/55 (0.00%)  0
Investigations     
Laboratory investigations  1 [1]  1/55 (1.82%)  1 0/55 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Fatigue  1  1/55 (1.82%)  1 0/55 (0.00%)  0
Nervous system disorders     
Drowsiness  1  1/55 (1.82%)  1 0/55 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Spontaneous miscarriage  1  0/55 (0.00%)  0 2/55 (3.64%)  2
Early Toxicosis During Pregnancy  1  0/55 (0.00%)  0 1/55 (1.82%)  1
Abnormal vaginal bleeding  1  0/55 (0.00%)  0 1/55 (1.82%)  1
Spotting  1  1/55 (1.82%)  1 1/55 (1.82%)  1
Lower abdominal pain  1  2/55 (3.64%)  2 4/55 (7.27%)  4
Reproductive system and breast disorders     
Menses  1  0/55 (0.00%)  0 1/55 (1.82%)  1
Ovarian hyperstimulation syndrome  1 [2]  4/55 (7.27%)  4 2/55 (3.64%)  2
Decrease in breast sensitivity  1  2/55 (3.64%)  2 0/55 (0.00%)  0
Lower abdominal pain  1  3/55 (5.45%)  3 1/55 (1.82%)  1
Pains in the lower abdomen  1  1/55 (1.82%)  1 0/55 (0.00%)  0
Abnormal vaginal bleeding  1  3/55 (5.45%)  3 1/55 (1.82%)  1
Spotting  1  2/55 (3.64%)  2 0/55 (0.00%)  0
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
[1]
Erythrocyte level increase in urine
[2]
Patients with negative pregnancy test
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: Mikhail Polzikov (PhD)
Organization: IVFarma LLC
Phone: +74996455342 ext 1
EMail: mikhail.polzikov@ivfarma.ru
Publications of Results:
M. Polzikov, Z. Barakhoeva, S. Yakovenko, M. Ovchinnikova, L.Vovk, Y. Fetisova. A multicenter, randomized study comparing the efficacy of follitropin alpha biosimilar and the original follitropin alpha. Abstracts of the 35th Annual Meeting of the ESHRE, Vienna, Austria 24 to 26 June 2019 (abstract P-649), Human Reproduction, 2019; Vol. 34, Suppl. 1, p. i439.
Layout table for additonal information
Responsible Party: IVFarma LLC
ClinicalTrials.gov Identifier: NCT03088137    
Other Study ID Numbers: FSG-03-01
First Submitted: March 2, 2017
First Posted: March 23, 2017
Results First Submitted: October 13, 2018
Results First Posted: June 6, 2019
Last Update Posted: August 21, 2019