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A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa

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ClinicalTrials.gov Identifier: NCT00257556
Recruitment Status : Completed
First Posted : November 23, 2005
Results First Posted : February 26, 2010
Last Update Posted : February 26, 2010
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infertility
Interventions Drug: Menotrophin
Drug: Follitropin alfa
Enrollment 80
Recruitment Details  
Pre-assignment Details Ninety (90) participants were screened and 80 participants randomized.
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG) A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Period Title: Overall Study
Started 38 42
All Patients Treated Population 37 [1] 39 [2]
Completed 24 32
Not Completed 14 10
Reason Not Completed
Adverse Event             1             4
Physician Decision             6             0
Did not meet hCG criterion             3             0
other reason             4             6
[1]
Also the safety population. One randomized patient did not receive study medication.
[2]
Also the safety population. Three randomized patients did not receive study medication.
Arm/Group Title Menotrophin Follitropin Alfa Total
Hide Arm/Group Description Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG) A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)). Total of all reporting groups
Overall Number of Baseline Participants 37 39 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 39 participants 76 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
37
 100.0%
39
 100.0%
76
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 39 participants 76 participants
30.7  (3.45) 30.9  (2.67) 30.8  (3.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 39 participants 76 participants
Female
37
 100.0%
39
 100.0%
76
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Tobacco Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 39 participants 76 participants
Smoker 4 8 12
Ex-smoker 8 5 13
Never Smoked 25 26 51
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms/Meters squared
Number Analyzed 37 participants 39 participants 76 participants
24.02  (3.689) 23.81  (3.731) 23.91  (3.687)
[1]
Measure Description: Body mass index (BMI) is measure of body fat based on height and weight that applies to both adult men and women
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 37 participants 39 participants 76 participants
74.1  (8.83) 73.8  (9.96) 74.0  (9.37)
Pulse  
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 37 participants 39 participants 76 participants
75.7  (9.63) 74.5  (9.16) 75.1  (9.35)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 37 participants 39 participants 76 participants
115.3  (12.50) 116.1  (14.55) 115.7  (13.51)
1.Primary Outcome
Title Number of Participants With an Ongoing Pregnancy
Hide Description Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.
Time Frame Approx week 13; 9 weeks or more after the 1st positive pregnancy test
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated population
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description:
Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Number of Participants Analyzed 37 39
Measure Type: Number
Unit of Measure: participants
14 13
2.Primary Outcome
Title Percentage of Participants With an Ongoing Pregnancy
Hide Description Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.
Time Frame Approx week 13; 9 weeks or more after the first positive pregnancy test
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated population. Two menotrophin patients did not have pregnancy outcome data recorded in this timeframe but were later recorded as having live births so are included here as "YES" for ongoing pregnancy.
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description:
Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Number of Participants Analyzed 37 39
Measure Type: Number
Unit of Measure: percentage of participants
37.8 33.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Menotrophin, Follitropin Alfa
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.045
Confidence Interval 95%
-0.170 to 0.260
Estimation Comments A two-sided 95% continuity-corrected confidence interval for the difference in percentages, based on the normal approximation
3.Secondary Outcome
Title Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters
Hide Description The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met.
Time Frame Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients population
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description:
Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Number of Participants Analyzed 37 39
Measure Type: Number
Unit of Measure: participants
Did not meet criterion 10 3
3 follicles ≥ 17 mm in diameter 11 11
4 follicles ≥ 17 mm in diameter 7 10
5 follicles ≥ 17 mm in diameter 2 10
6 follicles ≥ 17 mm in diameter 4 1
7 follicles ≥ 17 mm in diameter 0 0
8 follicles ≥ 17 mm in diameter 1 3
9 follicles ≥ 17 mm in diameter 0 0
10 follicles ≥ 17 mm in diameter 1 0
11-14 follicles ≥ 17 mm in diameter 0 0
15 follicles ≥ 17 mm in diameter 0 1
16 follicles ≥ 17 mm in diameter 1 0
4.Secondary Outcome
Title Participants With Varying Numbers of Oocytes Retrieved
Hide Description Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with >= 17mm in diameter.
Time Frame Approximately study day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients population.
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description:
Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Number of Participants Analyzed 23 29
Measure Type: Number
Unit of Measure: participants
0 oocytes retrieved 1 0
1 oocyte retrieved 1 1
2 oocytes retrieved 3 1
3 oocytes retrieved 3 1
4 oocytes retrieved 2 2
5 oocytes retrieved 2 5
6 oocytes retrieved 4 4
7 oocytes retrieved 2 2
8 oocytes retrieved 2 4
9 oocytes retrieved 2 2
10 oocytes retrieved 1 3
11 oocytes retrieved 0 0
12 oocytes retrieved 0 4
13 oocytes retrieved 0 1
14 oocytes retrieved 1 0
15 oocytes retrieved 0 3
16 oocytes retrieved 1 2
17-18 oocytes retrieved 0 0
19 oocytes retrieved 1 2
20 oocytes retrieved 0 0
21 oocytes retrieved 1 0
22 oocytes retrieved 0 0
23 oocytes retrieved 0 1
5.Secondary Outcome
Title Participants With Varying Numbers of Pronuclear Stage Oocytes
Hide Description Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.
Time Frame Approximately study day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated population
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description:
Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Number of Participants Analyzed 25 35
Measure Type: Number
Unit of Measure: participants
1 pronuclear stage oocyte 1 0
2 pronuclear stage oocytes 8 6
3 pronuclear stage oocytes 1 3
4 pronuclear stage oocytes 2 7
5 pronuclear stage oocytes 4 7
6 pronuclear stage oocytes 1 0
7 pronuclear stage oocytes 2 2
8 pronuclear stage oocytes 2 2
9 pronuclear stage oocytes 1 1
10 pronuclear stage oocytes 1 1
11 pronuclear stage oocytes 2 0
12 pronuclear stage oocytes 0 4
13 pronuclear stage oocytes 0 1
14-16 pronuclear stage oocytes 0 0
17 pronuclear stage oocytes 0 1
6.Secondary Outcome
Title Participants With Varying Numbers of Embryos Transferred
Hide Description Number of participants with various categories of numbers of embryos transferred.
Time Frame Approximately study day 17
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated population
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description:
Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Number of Participants Analyzed 24 33
Measure Type: Number
Unit of Measure: participants
0 embryos transferred 0 1
1 embryo transferred 3 1
2 embryos transferred 21 28
3 embryos transferred 0 3
7.Secondary Outcome
Title Participants With Varying Numbers of Embryos Frozen
Hide Description Number of participants with different categories of number of embryos frozen.
Time Frame Approximately study day 17
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated population
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description:
Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Number of Participants Analyzed 24 33
Measure Type: Number
Unit of Measure: participants
0 embryos frozen 16 22
1 embryo frozen 1 0
2 embryos frozen 2 1
3 embryos frozen 1 4
4 embryos frozen 4 2
5 embryos frozen 0 2
6-8 embryos frozen 0 0
9 embryos frozen 0 1
10 embryos frozen 0 1
8.Secondary Outcome
Title Mean Number of Days Stimulated With Gonadotrophins
Hide Description Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination.
Time Frame study days 1 - 13
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated population
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description:
Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Number of Participants Analyzed 37 39
Mean (Standard Deviation)
Unit of Measure: days
9.2  (1.71) 8.9  (1.07)
9.Secondary Outcome
Title Pregnancy Outcomes
Hide Description Long term follow-up to determine the outcome of the pregnancy.
Time Frame Approximately 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated population
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description:
Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Number of Participants Analyzed 17 17
Measure Type: Number
Unit of Measure: participants
Miscarriage 4 4
Pre-term: 1 live birth 1 1
Pre-term: 2 live births 2 3
Pre-term stillbirth 0 1
Full term: 1 live birth 7 6
Full term: 2 live births 3 2
10.Secondary Outcome
Title Mean Endometrial Thickness
Hide Description Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.
Time Frame Day 7 or 9 or 11 or 13
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated population
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description:
Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Number of Participants Analyzed 27 38
Mean (Standard Deviation)
Unit of Measure: millimeters
11.7  (2.73) 11.0  (2.31)
11.Secondary Outcome
Title Mean Estradiol Level
Hide Description Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.
Time Frame Day 7 or 9 or 11 or 13
Hide Outcome Measure Data
Hide Analysis Population Description
All patient treated population
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description:
Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Overall Number of Participants Analyzed 27 38
Mean (Standard Deviation)
Unit of Measure: picomoles / liter
6706.6  (4109.26) 6268.3  (4132.11)
Time Frame [Not Specified]
Adverse Event Reporting Description The 'all patients treated' population is the same as the safety population in this study.
 
Arm/Group Title Menotrophin Follitropin Alfa
Hide Arm/Group Description Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG) A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
All-Cause Mortality
Menotrophin Follitropin Alfa
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Menotrophin Follitropin Alfa
Affected / at Risk (%) Affected / at Risk (%)
Total   4/37 (10.81%)   9/39 (23.08%) 
Gastrointestinal disorders     
Abdominal Pain  1  0/37 (0.00%)  2/39 (5.13%) 
Abdominal Pain Lower  1  0/37 (0.00%)  1/39 (2.56%) 
Constipation  1  0/37 (0.00%)  1/39 (2.56%) 
Vomiting  1  0/37 (0.00%)  1/39 (2.56%) 
General disorders     
Pyrexia  1  0/37 (0.00%)  1/39 (2.56%) 
Pregnancy, puerperium and perinatal conditions     
Abortion Spontaneous  1  1/37 (2.70%)  3/39 (7.69%) 
Abortion Imminent  1  1/37 (2.70%)  0/39 (0.00%) 
Renal and urinary disorders     
Dysuria  1  0/37 (0.00%)  1/39 (2.56%) 
Reproductive system and breast disorders     
Ovarian Hyperstimulation Syndrome  1  2/37 (5.41%)  3/39 (7.69%) 
Uterine Haemorrhage  1  0/37 (0.00%)  1/39 (2.56%) 
Vaginal Haemorrhage  1  0/37 (0.00%)  1/39 (2.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Menotrophin Follitropin Alfa
Affected / at Risk (%) Affected / at Risk (%)
Total   18/37 (48.65%)   21/39 (53.85%) 
Gastrointestinal disorders     
Abdominal Distension  1  1/37 (2.70%)  4/39 (10.26%) 
Abdominal Pain  1  0/37 (0.00%)  2/39 (5.13%) 
Abdominal Pain Lower  1  1/37 (2.70%)  2/39 (5.13%) 
Constipation  1  0/37 (0.00%)  2/39 (5.13%) 
Nausea  1  3/37 (8.11%)  0/39 (0.00%) 
Vomiting  1  1/37 (2.70%)  3/39 (7.69%) 
General disorders     
Injection Site Bruising  1  3/37 (8.11%)  2/39 (5.13%) 
Injection Site Erythema  1  6/37 (16.22%)  4/39 (10.26%) 
Injection Site Haemorrhage  1  0/37 (0.00%)  3/39 (7.69%) 
Injection Site Pruritus  1  7/37 (18.92%)  2/39 (5.13%) 
Injection Site Rash  1  0/37 (0.00%)  2/39 (5.13%) 
Injection Site Swelling  1  4/37 (10.81%)  4/39 (10.26%) 
Infections and infestations     
Nasopharyngitis  1  2/37 (5.41%)  0/39 (0.00%) 
Nervous system disorders     
Dizziness  1  1/37 (2.70%)  2/39 (5.13%) 
Headache  1  1/37 (2.70%)  6/39 (15.38%) 
Reproductive system and breast disorders     
Breast Tenderness  1  1/37 (2.70%)  3/39 (7.69%) 
Ovarian Hyperstimulation Syndrome  1  2/37 (5.41%)  4/39 (10.26%) 
Vaginal Haemorrhage  1  2/37 (5.41%)  0/39 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  0/37 (0.00%)  2/39 (5.13%) 
Skin Reaction  1  2/37 (5.41%)  3/39 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The only disclosure restiction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
EMail: DK0-Disclosure@ferring.com
Layout table for additonal information
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00257556     History of Changes
Other Study ID Numbers: FE999906 CS004 (PROSPECT)
2004-001307-35 ( Registry Identifier: EudraCT )
First Submitted: November 22, 2005
First Posted: November 23, 2005
Results First Submitted: January 8, 2010
Results First Posted: February 26, 2010
Last Update Posted: February 26, 2010