Oocyte Cryopreservation
Conditions
Brief summary
Phase IV, prospective multicenter, observational Registry will track cycle outcomes for subjects who are thawing frozen oocytes for subsequent use through in vitro fertilization (IVF) and embryo transfer (ET)
Detailed description
Subjects will be enrolled at as many ART clinics that offer oocyte cryopreservation and are willing to participate in the Registry. Oocytes will be retrieved and cryopreserved from autologous or heterologous donors. When the subject decides she would like to get pregnant, oocytes will be thawed, fertilized and the resultant embryos will be transferred to the oocyte donor (for autologous use) or to another recipient (for heterologous use). The treatment regimen will be completed with births and well-baby follow-up of children at 12 months of age. Information on children will be submitted by their parents to the Investigators. Data collection for the Registry will be active for a maximum of five (5) years, including three (3) years of enrollment and two (2) additional years to complete the well-baby follow-up for all the children.
Interventions
None listed
Sponsors
EMD Serono
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be in an ART program * Donor and recipients must be of reproductive age (18-50 years old, inclusive at the time of oocyte freezing and/or thawing) who intend to achieve a pregnancy by utilizing frozen thawed autologous or heterologous oocytes * Female and partner (if applicable) must voluntarily provide written informed consent/HIPAA authorization prior to any Registry-related data collection * Female and partner (if applicable) must be willing to provide a second written informed consent following each live birth prior to any Registry- related data collection on birth characteristics and twelve (12) month evaluation of offspring * Children born from women who take part in this registry from birth to 12 months (+/- 1 month) of age
Exclusion criteria
* Have clinically significant systemic disease * Have abnormal, undiagnosed gynecological bleeding * Have any contraindication to Controlled Ovarian Stimulation (COS) for ART and to gonadotropins to be used in ART * Also, in a rare situation, are undergoing ET with mixed embryos generated from fresh oocytes produced in the current cycle as well as frozen embryos generated from nonfrozen oocytes obtained in a previous ART cycle * Children born from women who do not take part in this Registry * Any offspring of woman who are not Registry subjects cannot take part in this registry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thawing Cycle Level Live Birth Rate | Birth of one or more live babies | Live birth rate per thawing cycle was calculated from the number of live births divided by the number of oocytes thawed less the number of embryos cryopreserved from thawed oocytes, averaged over all thawing cycles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oocyte Level Live Birth Rate | Birth of one or more live babies | Oocyte Level Live Birth Rate was calculated from the total number of live births divided by the total number of oocytes thawed less the total number of embryos cryopreserved from thawed oocytes |
| Number of Live Babies | Birth of one or more live babies | — |
| Number of Oocytes Frozen | At cryopreservation | — |
| Number of Clinical Pregnancies | At time of ultrasound after embryo transfer | Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat. |
| Oocyte Survival Rate | At time of fertilization | Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle |
| Implantation Rate | At time of ultrasound after embryo transfer | Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles |
| Number of Miscarriages | Anytime after embryo transfer | Number of pregnancy outcomes reported as spontaneous abortions |
| Number of Oocytes Thawed | At start of thawing cycle | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Slow Freeze Subjects that participated in one or more slow-freeze cycles | 49 |
| Vitrification Subjects that participated in one or more vitrification cycles | 148 |
| Pre-Freeze Discontinuations Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze). | 11 |
| Total | 208 |
Baseline characteristics
| Characteristic | Total | Slow Freeze | Vitrification | Pre-Freeze Discontinuations |
|---|---|---|---|---|
| Age, Customized 35-37 years | 29 Participants | 3 Participants | 24 Participants | 2 Participants |
| Age, Customized <35 years | 43 Participants | 4 Participants | 34 Participants | 5 Participants |
| Age, Customized 38-40 years | 47 Participants | 15 Participants | 30 Participants | 2 Participants |
| Age, Customized 41-42 years | 30 Participants | 4 Participants | 26 Participants | 0 Participants |
| Age, Customized 43-44 years | 29 Participants | 13 Participants | 15 Participants | 1 Participants |
| Age, Customized > 44 years | 30 Participants | 10 Participants | 19 Participants | 1 Participants |
| BMI | 23.7 Kg/m^2 STANDARD_DEVIATION 4.1 | 24.6 Kg/m^2 STANDARD_DEVIATION 5.2 | 23.4 Kg/m^2 STANDARD_DEVIATION 3.6 | 19.7 Kg/m^2 STANDARD_DEVIATION 0 |
| Donor Age | 25.7 Years STANDARD_DEVIATION 2.8 | 25.1 Years STANDARD_DEVIATION 2.7 | 26.0 Years STANDARD_DEVIATION 2.8 | NA Years |
| Sex: Female, Male Female | 208 Participants | 49 Participants | 148 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Thawing Cycle Level Live Birth Rate
Live birth rate per thawing cycle was calculated from the number of live births divided by the number of oocytes thawed less the number of embryos cryopreserved from thawed oocytes, averaged over all thawing cycles.
Time frame: Birth of one or more live babies
Population: Live birth rate per thaw cycle(%)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Slow Freezing | Thawing Cycle Level Live Birth Rate | 12.4 % of oocytes thawed per cycle |
| Vitrification | Thawing Cycle Level Live Birth Rate | 15.0 % of oocytes thawed per cycle |
| All Participants | Thawing Cycle Level Live Birth Rate | 13.6 % of oocytes thawed per cycle |
Secondary
Implantation Rate
Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles
Time frame: At time of ultrasound after embryo transfer
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Slow Freezing | Implantation Rate | 15.9 Implantation Rate (%) | Standard Deviation 24.1 |
| Vitrification | Implantation Rate | 41.7 Implantation Rate (%) | Standard Deviation 43.4 |
| All Participants | Implantation Rate | 35.1 Implantation Rate (%) | Standard Deviation 40.9 |
Secondary
Number of Clinical Pregnancies
Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat.
Time frame: At time of ultrasound after embryo transfer
Population: Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Slow Freezing | Number of Clinical Pregnancies | 18 Number of Clinical Pregnancies |
| Vitrification | Number of Clinical Pregnancies | 73 Number of Clinical Pregnancies |
| All Participants | Number of Clinical Pregnancies | 91 Number of Clinical Pregnancies |
Secondary
Number of Live Babies
Time frame: Birth of one or more live babies
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Slow Freezing | Number of Live Babies | 17 Number of live births |
| Vitrification | Number of Live Babies | 84 Number of live births |
| All Participants | Number of Live Babies | 101 Number of live births |
Secondary
Number of Miscarriages
Number of pregnancy outcomes reported as spontaneous abortions
Time frame: Anytime after embryo transfer
Population: Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Slow Freezing | Number of Miscarriages | 4 Number of Miscarriages |
| Vitrification | Number of Miscarriages | 10 Number of Miscarriages |
| All Participants | Number of Miscarriages | 14 Number of Miscarriages |
Secondary
Number of Oocytes Frozen
Time frame: At cryopreservation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Slow Freezing | Number of Oocytes Frozen | 1144 Number of Oocytes Frozen |
| Vitrification | Number of Oocytes Frozen | 3721 Number of Oocytes Frozen |
| All Participants | Number of Oocytes Frozen | 4865 Number of Oocytes Frozen |
Secondary
Number of Oocytes Thawed
Time frame: At start of thawing cycle
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Slow Freezing | Number of Oocytes Thawed | 416 Number of oocytes thawed |
| Vitrification | Number of Oocytes Thawed | 1282 Number of oocytes thawed |
| All Participants | Number of Oocytes Thawed | 1698 Number of oocytes thawed |
Secondary
Oocyte Level Live Birth Rate
Oocyte Level Live Birth Rate was calculated from the total number of live births divided by the total number of oocytes thawed less the total number of embryos cryopreserved from thawed oocytes
Time frame: Birth of one or more live babies
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Slow Freezing | Oocyte Level Live Birth Rate | 4.2 % of all oocytes thawed |
| Vitrification | Oocyte Level Live Birth Rate | 7.4 % of all oocytes thawed |
| All Participants | Oocyte Level Live Birth Rate | 6.5 % of all oocytes thawed |
Secondary
Oocyte Survival Rate
Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle
Time frame: At time of fertilization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Slow Freezing | Oocyte Survival Rate | 73.2 Oocyte survival rate (%) | Standard Deviation 26.2 |
| Vitrification | Oocyte Survival Rate | 83.3 Oocyte survival rate (%) | Standard Deviation 20.9 |
| All Participants | Oocyte Survival Rate | 80.6 Oocyte survival rate (%) | Standard Deviation 22.8 |