Controlled Ovarian Stimulation, Infertility
Conditions
Keywords
COS, ART, Infertility
Brief summary
The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in normogonadotrophic women.
Interventions
DRUGrecombinant luteinizing hormone (r-LH)
administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
Sponsors
Regionshospitalet Viborg, Skive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Women who plan to undergo IVF or ICSI treatment * Woman's age \> 18 years but ≤ 35 years * Regular menstrual cycle (25-34 days) * BMI 18 to 30 inclusive * Signed patient information and informed consent forms
Exclusion criteria
* PCOS * More than 2 prior IVF/ICSI attempts * Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Oestradiol Concentration on the Day of Ovulation Induction | treatment day 10 to 14 |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 50 |
| 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) | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Recombinant Luteinizing Hormone | Recombinant Human Chorionic Gonadotrofin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Age Continuous | 30.1 years STANDARD_DEVIATION 3.2 | 29.7 years STANDARD_DEVIATION 3.1 | 29.9 years STANDARD_DEVIATION 3.1 |
| Region of Enrollment Denmark | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
The Oestradiol Concentration on the Day of Ovulation Induction
Time frame: treatment day 10 to 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recombinant Human Chorionic Gonadotrofin | The Oestradiol Concentration on the Day of Ovulation Induction | 11482 pmol/L | Standard Deviation 8210 |
| Recombinant Luteinizing Hormone | The Oestradiol Concentration on the Day of Ovulation Induction | 12262 pmol/L | Standard Deviation 8100 |