Controlled Ovarian Stimulation
Conditions
Keywords
Reproductive, techniques, assisted
Brief summary
The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).
Interventions
DRUGganirelix
On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration.
DRUGtriptorelin
a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Treatment with recFSH will start 14 days later if treatment with triptorelin has resulted in downregulation, i.e. serum E2 \<= 50 pg/ml (\<= 200pmol/l). In case the hypogonadotropic state is not reached after 14 days of pretreatment, the dose of triptorelin will be increased to 0.1 mg. If downregulation is not reached within 28 days of pre-treatment with triptorelin, the subject will be discontinued from further hormonal treatment. The daily dose of triptorelin is sustained up to and including the day of hCG.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* females of infertile couples for whom COS and IVF or ICSI is indicated * body mass index between 18 and 29 kg/m2 * willing and able to give written informed consent.
Exclusion criteria
* More than three previous COS cycles for assisted reproduction since last established ongoing pregnancy (if applicable) * History of no or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment * Less than 2 ovaries or any other ovarian abnormality including endometrioma * Presence of unilateral or bilateral hydrosalpinx * Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of at least one ovary * History of or current polycystic ovary syndrome (PCOS) * History of/or current endocrine abnormality * Any clinically relevant hormone value outside the reference range during the early follicular phase * Any clinically significant abnormal laboratory value * Hypertension or currently treated hypertension * Recent history of current epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary disease * Alcohol or drug abuse, or history thereof * Current serious allergic symptoms * Abnormal cervical smear * Known hypersensitivity to gonadotropin releasing hormone (GnRH) or its analogs; * Contra-indications for the use of gonadotropins * Use of hormonal preparations within 1 month prior to the date of signing consent; * Administration of any investigational product within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met. | At completion of ovarian stimulation; maximally after 18 days of recFSH administration. | The hCG criterion is met the first day that 3 follicles \>= 17 mm are observed. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ganirelix 0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG). | 113 |
| Triptorelin 0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG | 120 |
| Total | 233 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Fertilization failure | 0 | 1 |
| Overall Study | No/too few embryos/ bad quality embryos | 3 | 2 |
| Overall Study | No/too few oocytes/bad quality oocytes | 1 | 1 |
| Overall Study | Pregnancy | 0 | 3 |
| Overall Study | Risk for hyperstimulation | 2 | 9 |
Baseline characteristics
| Characteristic | Ganirelix | Triptorelin | Total |
|---|---|---|---|
| Age, Continuous | 29.3 years STANDARD_DEVIATION 2.8 | 29.1 years STANDARD_DEVIATION 3 | 29.2 years STANDARD_DEVIATION 2.9 |
| Region of Enrollment China | 113 participants | 120 participants | 233 participants |
| Sex: Female, Male Female | 113 Participants | 120 Participants | 233 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 | 13 / 112 | 13 / 120 |
| serious Total, serious adverse events | 4 / 112 | 2 / 120 |
Outcome results
Primary
The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.
The hCG criterion is met the first day that 3 follicles \>= 17 mm are observed.
Time frame: At completion of ovarian stimulation; maximally after 18 days of recFSH administration.
Population: The number of participants for this analysis included only those participants in the intent-to-treat (ITT) group who received hCG and for whom data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ganirelix | The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met. | 1272.0 international units (IU) | Standard Deviation 265.8 |
| Triptorelin | The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met. | 1415.6 international units (IU) | Standard Deviation 355.6 |
p-value: <0.001Cochran-Whitehead