Infertility
Conditions
Brief summary
The chances to achieve pregnancy after retrieving \>15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle. The purpose of this study is to compare the outcome of these two approaches.
Interventions
PROCEDUREoocyte vitrification
PROCEDUREembryo freezing
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* IVF patients * ovulation trigger with Decapeptyl 0.2 mg because of ovarian hyper-response: E2 on trigger day .12,000 pmol/l and/or \>15 oocytes. * Normal uterus
Exclusion criteria
* \<20% fertilization rate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Heart Activity 1 Month Post Embryo Transfer | 1 month after embryo transfer | Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oocyte Vitrification All retrieved mature oocytes will be vitrified.
oocyte vitrification | 3 |
| Embryo Freezing All retrieved oocytes will be fertilized, and resulting embryos will be frozen.
embryo freezing | 8 |
| Total | 11 |
Baseline characteristics
| Characteristic | Embryo Freezing | Oocyte Vitrification | 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 | 8 Participants | 3 Participants | 11 Participants |
| Age, Continuous | 25 years STANDARD_DEVIATION 2.6 | 29.6 years STANDARD_DEVIATION 5.5 | 28.3 years STANDARD_DEVIATION 5.2 |
| Region of Enrollment Israel | 8 participants | 3 participants | 11 participants |
| Sex: Female, Male Female | 8 Participants | 3 Participants | 11 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 / 3 | 0 / 8 |
| serious Total, serious adverse events | 0 / 3 | 0 / 8 |
Outcome results
Primary
Fetal Heart Activity 1 Month Post Embryo Transfer
Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer
Time frame: 1 month after embryo transfer
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oocyte Vitrification | Fetal Heart Activity 1 Month Post Embryo Transfer | 0 participants with fetal heart activity |
| Embryo Freezing | Fetal Heart Activity 1 Month Post Embryo Transfer | 4 participants with fetal heart activity |