A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age

This study has been terminated.
(Trial was terminated due to low recruitment rate)
Sponsor:
Collaborator:
Merck, S.L., Spain
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01079949
First received: March 2, 2010
Last updated: January 26, 2014
Last verified: January 2014
Results First Received: November 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Infertility
Ovulation Induction
Interventions: Drug: r-hLH + r-hFSH
Drug: r-hFSH
Drug: Recombinant Human Choriogonadotropin (r-hCG)
Drug: GnRH antagonist

  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
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
r-hFSH + r-hLH Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
r-hFSH Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.

Participant Flow:   Overall Study
    r-hFSH + r-hLH     r-hFSH  
STARTED     46     47  
COMPLETED     31     34  
NOT COMPLETED     15     13  
Withdrawal before r-hCG administration                 2                 3  
Withdrawal between rhCG-ovum pickup(OPU)                 4                 8  
Withdrawal between OPU - embryo transfer                 8                 2  
Randomized but not treated                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
r-hFSH + r-hLH Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
r-hFSH Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
Total Total of all reporting groups

Baseline Measures
    r-hFSH + r-hLH     r-hFSH     Total  
Number of Participants  
[units: participants]
  45     47     92  
Age  
[units: years]
Mean ± Standard Deviation
  36.6  ± 2.6     36.3  ± 3.0     36.4  ± 2.8  
Gender  
[units: participants]
     
Female     45     47     92  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Number of Oocytes Retrieved   [ Time Frame: Ovum pick-up (OPU) day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) ]

2.  Primary:   Number of Mature Oocytes Retrieved   [ Time Frame: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) ]

3.  Primary:   Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)   [ Time Frame: S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) ]

4.  Primary:   Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)   [ Time Frame: S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) ]

5.  Primary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) ]

6.  Secondary:   Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day   [ Time Frame: r-hCG day (end of stimulation cycle [approximately 9 days]) ]

7.  Secondary:   Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day   [ Time Frame: r-hCG day (end of stimulation cycle [approximately 9 days]) ]

8.  Secondary:   Number of Fertilized Oocytes (2 Pronuclei [PN])   [ Time Frame: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) ]

9.  Secondary:   Number of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN   [ Time Frame: Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days]) ]

10.  Secondary:   Number and Quality of Embryos   [ Time Frame: Day 2-3 post OPU (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) ]

11.  Secondary:   Implantation Rate   [ Time Frame: Day 35-42 post OPU (34-38 hours post r-hCG day {end of stimulation cycle [approximately 9 days]}) ]

12.  Secondary:   Number of Participants With Clinical Pregnancies   [ Time Frame: Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days]) ]

13.  Secondary:   Number of Participants in Whom Recombinant Human Chorionic Gonadotropin (r-hCG) Was Not Administered Due to Poor Response   [ Time Frame: r-hCG day (end of stimulation cycle [approximately 9 days]) ]

14.  Secondary:   Number of Ovarian Stimulation Days   [ Time Frame: Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days]) ]

15.  Secondary:   Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)   [ Time Frame: Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days]) ]

16.  Secondary:   Estradiol (E2) Levels on r-hCG Day   [ Time Frame: r-hCG day (end of stimulation cycle [approximately 9 days]) ]

17.  Secondary:   Follicular Levels of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (hCG) at Ovum Pick up (OPU)   [ Time Frame: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) ]

18.  Secondary:   Follicular Levels of Estradiol (E2) at Ovum Pick up (OPU)   [ Time Frame: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) ]

19.  Secondary:   Follicular Levels of Testosterone (T) at Ovum Pick up (OPU)   [ Time Frame: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) ]


  Serious Adverse Events


  Other Adverse Events


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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.  


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: NCT01079949     History of Changes
Other Study ID Numbers: 27262, 2006-005268-19
Study First Received: March 2, 2010
Results First Received: November 12, 2012
Last Updated: January 26, 2014
Health Authority: Spain: Spanish Agency of Medicines