Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle (Luveris in ART)

This study has been terminated.
Sponsor:
Collaborator:
Merck Serono S.P.A., Italy
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01071200
First received: February 18, 2010
Last updated: December 2, 2013
Last verified: December 2013
Results First Received: May 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Reproductive Techniques, Assisted
Interventions: Drug: Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH)
Drug: r-hFSH

  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
FSH + rhLH Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
Follicle-stimulating Hormone (FSH) FSH injection s.c. administered according to investigator’s discretion till r-hCG administration day.

Participant Flow:   Overall Study
    FSH + rhLH     Follicle-stimulating Hormone (FSH)  
STARTED     67     66  
COMPLETED     60     63  
NOT COMPLETED     7     3  
Lack of ovarian response                 1                 1  
No fertilization                 4                 0  
No oocytes retrieved                 1                 1  
Ovarian Hyper Stimulation Syndrome                 1                 0  
No viable 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.
No text entered.

Reporting Groups
  Description
FSH + rhLH Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
Follicle-stimulating Hormone (FSH) FSH injection s.c. administered according to investigator’s discretion till r-hCG administration day.
Total Total of all reporting groups

Baseline Measures
    FSH + rhLH     Follicle-stimulating Hormone (FSH)     Total  
Number of Participants  
[units: participants]
  67     66     133  
Age  
[units: years]
Mean ± Standard Deviation
  35.6  ± 2.9     35.0  ± 3.8     35.3  ± 3.4  
Gender  
[units: participants]
     
Female     67     66     133  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes   [ Time Frame: Baseline (Stimulation day 8 [S8]) until hCG day ]

2.  Secondary:   Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose   [ Time Frame: Baseline (S8) until hCG day ]

3.  Secondary:   Mean Number of Ovarian Stimulation Days   [ Time Frame: Baseline (S8) until hCG day ]

4.  Secondary:   Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day   [ Time Frame: Baseline (S8) and hCG day ]

5.  Secondary:   Mean Total Number of Retrieved Oocytes   [ Time Frame: 34-36 hours post-hCG (OPU) ]

6.  Secondary:   Mean Number of Mature Oocytes (Metaphase II)   [ Time Frame: 34-36 hours post-hCG (OPU) ]

7.  Secondary:   Fertilization Rate   [ Time Frame: 12-18 day post-hCG and/or Week 7 ]

8.  Secondary:   Number of Obtained Embryos   [ Time Frame: Day 3 post-hCG (Embryo transfer [ET]) ]

9.  Secondary:   Number of Transferred Embryos   [ Time Frame: Day 3 post-hCG (ET) ]

10.  Secondary:   Percentage of Participants With Pregnancy   [ Time Frame: 12-18 day post-hCG and/or Week 7 ]

11.  Secondary:   Percentage of Participants With Clinical Pregnancy   [ Time Frame: 12-18 day post-hCG and/or Week 7 ]

12.  Secondary:   Percentage of Participants With Implantation   [ Time Frame: 12-18 day post-hCG and/or Week 7 ]

13.  Secondary:   Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)   [ Time Frame: Baseline (S8) until 12-18 day post-hCG and/or Week 7 ]

14.  Secondary:   Number of Cycles Cancelled Due to Risk of OHSS   [ Time Frame: Baseline (S8) until 12-18 day post-hCG and/or Week 7 ]


  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: NCT01071200     History of Changes
Obsolete Identifiers: NCT00267761
Other Study ID Numbers: IMP25289, 2004-002218-13
Study First Received: February 18, 2010
Results First Received: May 14, 2012
Last Updated: December 2, 2013
Health Authority: Italy: Ethics Committee