Fertilization
Conditions
Keywords
In-vitro fertilization
Brief summary
The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.
Interventions
DRUGcorifollitropin alfa
On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.
DRUGFollitropin beta injection
Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Females of couples with an indication for COH and IVF or ICSI; * \>=18 and \<=39 years of age at the time of signing informed consent; * BMI \>=18 and \<=29 kg/m\^2; * Normal menstrual cycle length: 24-35 days; * Ejaculatory sperm (use of donated and/or frozen sperm is allowed); * Willing and able to sign informed consent.
Exclusion criteria
* History of/or any current (treated) endocrine abnormality; * History of ovarian hyperstimulation syndrome (OHSS); * History of/or current polycystic ovary syndrome (PCOS) or current polycystic ovaries according to USS (at least 10 follicles of 2-8 mm in each ovary); * More than three unsuccessful COH cycles since the last established ongoing pregnancy (if applicable); * History of non- or low ovarian response to FSH/hMG treatment; * Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual cycle day 2-7) as measured by the local laboratory (FSH, LH, E2, P, total T, TSH and prolactin): * Any clinically relevant abnormal laboratory value; * Less than 2 ovaries; * Any ovarian and/or abdominal abnormality interfering with ultrasound examination; * Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts); * Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease; * History of presence of alcohol or drug abuse within 12 months prior to signing informed consent; * Previous use of Org 36286; * Use of hormonal preparations within 1 month prior to randomization; * Hypersensitivity to Org 32489 (Puregon®) and/or Org 37462 (Orgalutran®) and/or Pregnyl® or any of their components; * Administration of investigational drugs within three months prior to signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cumulus-oocyte-complexes retrieved | 1 cycle |
Secondary
| Measure | Time frame |
|---|---|
| Treatment failure rate | 1 cycle |
Outcome results
None listed