Trial Outcomes & Findings for 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) (NCT NCT01339299)
NCT ID: NCT01339299
Last Updated: 2013-11-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
treatment day 10 to 14
Results posted on
2013-11-27
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Recombinant Human Chorionic Gonadotrofin
n=50 Participants
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
n=50 Participants
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
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
29.7 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
29.9 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: treatment day 10 to 14Outcome measures
| Measure |
Recombinant Human Chorionic Gonadotrofin
n=50 Participants
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
n=50 Participants
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)
|
|---|---|---|
|
The Oestradiol Concentration on the Day of Ovulation Induction
|
11482 pmol/L
Standard Deviation 8210
|
12262 pmol/L
Standard Deviation 8100
|
Adverse Events
Recombinant Human Chorionic Gonadotrofin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Recombinant Luteinizing Hormone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof, M.D. Peter Humaidan
Fertility Clinic Regional Hospital Skive
Phone: +45 78445760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place