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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)

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ClinicalTrials.gov Identifier: NCT01339299
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive

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)
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Recombinant Human Chorionic Gonadotrofin Recombinant Luteinizing Hormone
Hide Arm/Group Description

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)

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)

Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Recombinant Human Chorionic Gonadotrofin Recombinant Luteinizing Hormone Total
Hide Arm/Group Description

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)

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 of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
50
 100.0%
100
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
29.7  (3.1) 30.1  (3.2) 29.9  (3.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
50
 100.0%
50
 100.0%
100
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 50 participants 50 participants 100 participants
50 50 100
1.Primary Outcome
Title The Oestradiol Concentration on the Day of Ovulation Induction
Hide Description [Not Specified]
Time Frame treatment day 10 to 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recombinant Human Chorionic Gonadotrofin Recombinant Luteinizing Hormone
Hide Arm/Group Description:

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)

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)

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: pmol/L
11482  (8210) 12262  (8100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Recombinant Human Chorionic Gonadotrofin Recombinant Luteinizing Hormone
Hide Arm/Group Description

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)

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)

All-Cause Mortality
Recombinant Human Chorionic Gonadotrofin Recombinant Luteinizing Hormone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Recombinant Human Chorionic Gonadotrofin Recombinant Luteinizing Hormone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Recombinant Human Chorionic Gonadotrofin Recombinant Luteinizing Hormone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof, M.D. Peter Humaidan
Organization: Fertility Clinic Regional Hospital Skive
Phone: +45 78445760
EMail: peter.humaidan@viborg.rm.dk
Layout table for additonal information
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