Infertility
Conditions
Keywords
infertility, next generation sequencing
Brief summary
The investigators propose to perform a clinical randomized trial to evaluate the effect of a frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation rates; with the added benefit of a blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS).
Detailed description
1. Fresh group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (\*) biopsied on day 5, analyzed by NGS, and will have one or two euploid embryo transferred on day 6, in the am. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (\*). Any morulas developing to hatching blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle. 2. Frozen group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (\*) biopsied on day 5 or day 6, embryos will then be vitrified, analyzed by NGS, and will have one or two euploid embryo(s) thawed and transferred on a FET cycle, before noon. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (\*). (\*) Hatching blastocysts as described by Gardner and Schoolcraft (1999):
Interventions
OTHERPGD
PGD using Next generation sequencing
Sponsors
Reproductive Medicine Lab, LLC
Reprogenetics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
(pre-stimulation): * Age up to 42 years
Exclusion criteria
(pre-stimulation): * MESA and TESE patients * At least one partner carrier of a chromosomal abnormality * Egg donor cycle (sperm donor is acceptable) * Gender selection cycles * Thaw cycles * Any patient who cannot have a fresh embryo transfer * FSH above 12 or AMH less than 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | 8 weeks after replacement | determining whether a frozen or a fresh embryo transfer will improve implantation rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Mitochondrial DNA and implantation | When a fetal heartbeat is detected (8 weeks after implantation) | The second aim of this study is to determine retrospectively if mt DNA content is linked to implantation potential and if that is measurable by NGS. NGS provides the additional advantage that it can measure mitochondrial DNA, which it's content, seems to be inversely correlated with implantation (Fragouli et al 2013, ASRM). |
Countries
United States
Outcome results
None listed