ClinicalTrials.gov
ClinicalTrials.gov Menu

PERgoveriS In Stratified Treatment for Assisted Reproductive Technique (PERSIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01297465
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : February 24, 2014
Last Update Posted : February 24, 2014
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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

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 
Overall Participants Analyzed 
[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

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}]) ]
  Show Outcome Measure 1

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]) ]
  Show Outcome Measure 2

3.  Secondary:   Total Number of Stimulation Treatment Days   [ Time Frame: Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) ]
  Show Outcome Measure 3

4.  Secondary:   Implantation Rate   [ Time Frame: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]
  Show Outcome Measure 4

5.  Secondary:   Number of Fetal Sacs With Activity   [ Time Frame: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Fetal Hearts With Activity   [ Time Frame: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) ]
  Show Outcome Measure 6

7.  Secondary:   Clinical Pregnancy Rate   [ Time Frame: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]
  Show Outcome Measure 7

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]) ]
  Show Outcome Measure 8

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]) ]
  Show Outcome Measure 10

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]) ]
  Show Outcome Measure 11

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]) ]
  Show Outcome Measure 12

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]) ]
  Show Outcome Measure 13

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


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


Publications of Results:
H Behre, C Howles, S Longobardi. Luteinizing hormone supplementation from Day 1 versus 6 of ovarian stimulation in women aged 36-40 years: results from an open-label, randomized, multicentre, multinational trial. Human Reproduction. 2013;28(suppl 1)


Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01297465     History of Changes
Other Study ID Numbers: EMR 200061-504
2010-023534-23 ( EudraCT Number )
First Submitted: February 15, 2011
First Posted: February 16, 2011
Results First Submitted: October 23, 2013
Results First Posted: February 24, 2014
Last Update Posted: February 24, 2014