Infertility Clinical Trial
Official title:
Single Embryo Transfer of a Euploid Embryo Versus Double Embryo Transfer: A Randomized Controlled Trial
This study seeks to compare the pregnancy and delivery rates of patients who undergo a single embryo transfer, when the embryo has been tested and determined to be chromosomally normal, with pregnancy and delivery rates of patients who undergo a two (2) embryo transfer of untested embryos.
Status | Completed |
Enrollment | 175 |
Est. completion date | December 2014 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 43 Years |
Eligibility |
Inclusion Criteria: 1. Maximum of one (1) prior failed IVF cycle (a failed cycle is any cycle that did not deliver. Pregnancy losses are failed cycles. Ok to participate as a recipient in an egg donor cycle.) 2. Female partner less than 43 years old at time of onset of IVF cycle 3. Maximum prior day 3 follicle stimulation hormone (FSH) level of 12 (in RMA NJ laboratory) 4. Minimum anti-mullerian hormone (AMH)of 1.2 within 1 year 5. Normal uterine cavity demonstrated by saline sonogram, hysterosalpingogram or hysteroscopy within 1 year. 6. Male partner with greater than 100,000 total motile spermatozoa. Donor sperm ok. 7. Body Mass Index (BMI) less than or equal to 30 kg/m2. Exclusion Criteria: 1. Diagnosis of chronic anovulation (cycles typically longer than 90 days) 2. Diagnosis of endometrial insufficiency- prior cycle with endometrial thickness less than 6mm, abnormal endometrial echotexture, persistent endometrial fluid. 3. Clinical indication of aneuploidy screening (i.e. history of loss of chromosomally abnormal pregnancies) 4. Clinical indication for PGD for single-gene disorder (i.e. PGD is needed to select against the transfer of embryos affected with a specific condition) 5. Use of testicular aspiration or biopsy procedures to obtain sperm 6. Unevaluated ovarian mass or surgically confirmed stage IV endometriosis 7. Presence of hydrosalpinges which communicate with the endometrial cavity 8. Any contraindication to undergoing in vitro fertilization |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Reproductive Medicine Associated of Pennsylvania at lehigh Valley | Allentown | Pennsylvania |
United States | Reproductive Medicine Associated of New Jersey | Morristown | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Reproductive Medicine Associates of New Jersey | Ferring Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Live birth rate per randomized patient (single embryo transfer vs. 2 embryo transfer) | Compare live birth rates of patients who have a single embryo transfer of a chromosomally normal embryo with the live birth rates of patients who have two, untested embyros transferred. | 2 years | No |
Secondary | Twin live birth rate | Compare twin live birth rates of patients who have a single embryo transfer of a chromosomally normal embryo with the twin live birth rates of patients who have two, untested embryos transferred. | 2 years | No |
Secondary | Sustained implantation rate (number of viable fetuses beyond the first trimester per embryo transferred) | Compare sustained implantation rates of patients who have a single embryo transfer of a chromosomally normal embryo with the sustained implantation rates of patients who have two, untested embryos transferred. | 2 years | No |
Secondary | Live birth rate per embryo transfer | Compare live birth rates per transfer of patients who have a single embryo transfer of a chromosomally normal embryo with the live birth rates per transfer of patients who have two, untested embryos transferred. | 2 years | No |
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