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Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01339299
First Posted: April 20, 2011
Last Update Posted: November 27, 2013
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.
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive
Results First Submitted: September 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions: Controlled Ovarian Stimulation
Infertility
Interventions: Drug: recombinant luteinizing hormone (r-LH)
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
No text entered.

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
Recombinant Human Chorionic Gonadotrofin

25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )

recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)

Recombinant Luteinizing Hormone

150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)

recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)


Participant Flow:   Overall Study
    Recombinant Human Chorionic Gonadotrofin   Recombinant Luteinizing Hormone
STARTED   50   50 
COMPLETED   50   50 
NOT COMPLETED   0   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
Recombinant Human Chorionic Gonadotrofin

25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )

recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)

Recombinant Luteinizing Hormone

150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)

recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)

Total Total of all reporting groups

Baseline Measures
   Recombinant Human Chorionic Gonadotrofin   Recombinant Luteinizing Hormone   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   50   100 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   50   50   100 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.7  (3.1)   30.1  (3.2)   29.9  (3.1) 
Gender 
[Units: Participants]
     
Female   50   50   100 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Denmark   50   50   100 


  Outcome Measures

1.  Primary:   The Oestradiol Concentration on the Day of Ovulation Induction   [ Time Frame: treatment day 10 to 14 ]


  Serious Adverse Events


  Other Adverse Events


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof, M.D. Peter Humaidan
Organization: Fertility Clinic Regional Hospital Skive
phone: +45 78445760
e-mail: peter.humaidan@viborg.rm.dk



Responsible Party: Peter Humaidan, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier: NCT01339299     History of Changes
Other Study ID Numbers: 700642-603
2009-009375-35 ( EudraCT Number )
First Submitted: April 19, 2011
First Posted: April 20, 2011
Results First Submitted: September 25, 2013
Results First Posted: November 27, 2013
Last Update Posted: November 27, 2013