Infertility
Conditions
Brief summary
Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given. The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.
Interventions
DRUGGnRH agonist trigger
DRUGhCG trigger
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
* IVF patients with at least 4 consecutive failures. * On trigger day, no more than 10 follicles of 12 mm and up
Exclusion criteria
* History of moderate or severe OHSS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Heart Activity 1 Month After Oocyte Retrieval | 1 month after oocyte retrieval | Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval |
Secondary
| Measure | Time frame |
|---|---|
| Patients Comfort During the Luteal Phase | During 2 weeks from day of oocyte retrieval |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| hCG Trigger Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
hCG trigger | 2 |
| GnRH Agonist Trigger ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
GnRH agonist trigger | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | hCG Trigger | GnRH Agonist Trigger | Total |
|---|---|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 2.1 | 42 years STANDARD_DEVIATION 0 | 41.7 years STANDARD_DEVIATION 1.5 |
| Region of Enrollment Israel | 2 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 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 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Fetal Heart Activity 1 Month After Oocyte Retrieval
Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval
Time frame: 1 month after oocyte retrieval
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| hCG Trigger | Fetal Heart Activity 1 Month After Oocyte Retrieval | 0 participants with fetal heart activity |
| GnRH Agonist Trigger | Fetal Heart Activity 1 Month After Oocyte Retrieval | 0 participants with fetal heart activity |
Secondary
Patients Comfort During the Luteal Phase
Time frame: During 2 weeks from day of oocyte retrieval