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PERgoveriS In Stratified Treatment for Assisted Reproductive Technique (PERSIST)

This study has been completed.
Sponsor:
Collaborators:
Merck Serono S.A., Geneva
Merck A/S, Denmark
Merck OY, Finland
Merck Serono S.A.S, France
Merck Serono GmbH, Germany
Merck A.E., Greece
Merck B.V., Netherlands
Merck SP. Z.O.O., Poland
Merck Serono S.P.A., Italy
Merck Services U.K. Ltd, UK
LLC Merck, Russia
Merck spol. s r.o., Slovakia
Merck Pharma, K.S., Slovakia
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01297465
First received: February 15, 2011
Last updated: January 10, 2014
Last verified: January 2014
History of Changes
Results First Received: October 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Assisted Reproductive Techniques
Reproductive Technology, Assisted
Interventions: Drug: Gonal-f®
Drug: Pergoveris®
Drug: Recombinant human chorionic gonadotropin (r-hCG)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Gonal-f® Plus Pergoveris® Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
Pergoveris® Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.

Participant Flow:   Overall Study
    Gonal-f® Plus Pergoveris®     Pergoveris®  
STARTED     99     103  
COMPLETED     91     93  
NOT COMPLETED     8     10  
Lack of Ovarian Response                 1                 1  
Ovarian hyperstimulation syndrome risk                 0                 1  
No Oocytes Retrieved                 1                 1  
Poor oocyte quality                 0                 1  
No Fertilization                 6                 4  
All Embryos Discarded                 0                 1  
Intention to Freeze all Embryos                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.

Reporting Groups
  Description
Gonal-f® Plus Pergoveris® Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
Pergoveris® Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
Total Total of all reporting groups

Baseline Measures
    Gonal-f® Plus Pergoveris®     Pergoveris®     Total  
Number of Participants  
[units: participants]
 		  99     103     202  
Age  
[units: years]
Mean ± Standard Deviation 		  37.6  ± 1.16     37.4  ± 1.14     37.5  ± 1.15  
Gender  
[units: participants]
 		     
Female     99     103     202  
Male     0     0     0  
Race  
[units: participants]
 		     
Black     4     3     7  
Asian     4     6     10  
Other     2     2     4  
White     89     92     181  
Height  
[units: centimeter]
Mean ± Standard Deviation 		  166.1  ± 6.49     166.3  ± 6.47     166.2  ± 6.46  
Weight  
[units: kilogram]
Mean ± Standard Deviation 		  64.81  ± 10.364     65.82  ± 8.923     65.33  ± 9.645  



  Outcome Measures
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1.  Primary:   Total Number of Oocytes Retrieved   [ Time Frame: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}]) ]
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2.  Secondary:   Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)   [ Time Frame: Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) ]
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3.  Secondary:   Total Number of Stimulation Treatment Days   [ Time Frame: Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) ]
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4.  Secondary:   Implantation Rate   [ Time Frame: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]
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5.  Secondary:   Number of Fetal Sacs With Activity   [ Time Frame: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) ]
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6.  Secondary:   Number of Fetal Hearts With Activity   [ Time Frame: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) ]
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7.  Secondary:   Clinical Pregnancy Rate   [ Time Frame: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]
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8.  Secondary:   Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment   [ Time Frame: S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]
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9.  Secondary:   Biochemical Pregnancies Rate   [ Time Frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants With Multiple Pregnancies   [ Time Frame: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]
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11.  Secondary:   Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS)   [ Time Frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]
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12.  Secondary:   Number of Participants With Treatment-emergent Adverse Events   [ Time Frame: Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]
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13.  Secondary:   Systolic and Diastolic Arterial Blood Pressure Assessments   [ Time Frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]
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14.  Secondary:   Heart Rate Assessments   [ Time Frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


No publications provided


Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01297465     History of Changes
Other Study ID Numbers: EMR 200061-504, 2010-023534-23
Study First Received: February 15, 2011
Results First Received: October 23, 2013
Last Updated: January 10, 2014
Health Authority: Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation