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:
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier:
NCT01339299
First received: April 19, 2011
Last updated: September 25, 2013
Last verified: April 2011
Results First Received: September 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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
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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
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.
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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)

Total Total of all reporting groups

Baseline Measures
    Recombinant Human Chorionic Gonadotrofin     Recombinant Luteinizing Hormone     Total  
Number of Participants  
[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


No publications provided


Responsible Party: Peter Humaidan, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier: NCT01339299     History of Changes
Other Study ID Numbers: 700642-603, 2009-009375-35
Study First Received: April 19, 2011
Results First Received: September 25, 2013
Last Updated: September 25, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics