In Vitro Fertilization (IVF), Preimplantation Genetic Diagnosis (PGD), Preimplantation Gentic Screening (PGS)
Conditions
Keywords
Preimplantation Gentic Screening, PGS, In Vitro Fertilization, IVF, Preimplantation Genetic Diagnosis, PGD
Brief summary
Natera is recruiting patients for a research study evaluating pregnancy and implantation rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy. Healthy women undergoing IVF who are between the ages of 35 to 42 years are being recruited to participate in a randomized study. The purpose of this study is to determine whether PGS- testing of embryos created during IVF for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and implantation rates in patients when compared to patients whose embryos are not tested. PGS will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Natera. All subjects who qualify and enroll will receive discounted IVF medications (both TEST and CONTROL arms). If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.
Detailed description
If you meet the criteria below, you may be a candidate for this study. To participate in the study you must: * Be a healthy, pre-menopausal female, 35-42 years of age * Have a history of less than 3 consecutive miscarriages and no more than one failed IVF cycle * Agree to use Ferring Pharmaceutical products during stimulation * Agree to be randomly assigned to either the arm of the study receiving PGS (TEST arm)or the arm receiving no additional testing (CONTROL arm) Additional screening will be conducted to determine if you are eligible to enroll. All subjects who qualify and enroll will receive discounted IVF medications. If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.
Interventions
DEVICE24 Chromosome Aneuploidy Screening with Parental Support
Preimplantation Genetic Screening (PGS)
Sponsors
Ferring Pharmaceuticals
Natera, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Must agree to a follow-up visit at approximately 4-8 weeks gestation and a follow up phone call at 20 and 40 weeks gestation/livebirth. For patients assigned to the TEST group must agree to PGD testing and collection of buccal swab sample on newborn * At least 10 eggs retrieved * Must agree to use only Ferring products during stimulation * Normal uterine cavity detected on hysterosalpingogram (HSG), saline infusion sonogram (SIS), or hysteroscopy * Signed consent form
Exclusion criteria
* FSH ≥10 IU/L within past year prior to screening * 2 or more previously failed IVF cycles * Gestational or surrogate carrier, donor oocyte, donor sperm * History of recurrent pregnancy loss (3 or more consecutive miscarriages) * Severe male factor infertility defined as ejaculate sperm of \< 1million sperm/ml, or sperm obtained through testicular biopsy * Gender selection as primary indication * Maternal disease that is not clinically stable and known to impact the ability to become pregnant or carry a pregnancy to term (lupus, chronic liver or kidney disease, body mass index (BMI) \>35, uncontrolled hypertension, anti-phospholipid antibody, thrombophilia, insulin dependent diabetes) * Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests * Participation in any experimental drug study within 30 days prior to Screening * Prior hypersensitivity to any of the protocol drugs * Known history conveying increased risk for chromosome abnormality (beyond maternal age) or genetic disease in offspring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implantation Rate | Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation. | Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CONTROL Arm Subjects assigned to this arm of the study will receive no PGS testing. | 29 |
| TEST Arm Subjects assigned to this arm of the study will receive PGS testing.
24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS) | 30 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Protocol Violation | 4 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | CONTROL Arm | TEST Arm | Total |
|---|---|---|---|
| Age, Continuous | 38 years | 37.3 years | 37.7 years |
| Sex: Female, Male Female | 29 Participants | 30 Participants | 59 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 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
Primary
Implantation Rate
Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.
Time frame: Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.
Population: Patients who reached embryo transfer were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CONTROL Arm | Implantation Rate | 24 percentage of implantation per group |
| TEST Arm | Implantation Rate | 35 percentage of implantation per group |