Overview

This trial is active, not recruiting.

Condition infertility
Treatment pgd
Phase phase 2
Sponsor Reprogenetics
Collaborator Reproductive Medicine Lab, LLC
Start date September 2013
End date December 2015
Trial size 186 participants
Trial identifier NCT02000349, Reprogenetics-3.117

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose screening
Arm
(Experimental)
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 (*).
pgd PGD (Preimplantation Genetic Diagnosis)
PGD using Next generation sequencing
(Experimental)
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.
pgd PGD (Preimplantation Genetic Diagnosis)
PGD using Next generation sequencing

Primary Outcomes

Measure
Implantation rate
time frame: 8 weeks after replacement

Secondary Outcomes

Measure
Correlation of Mitochondrial DNA and implantation
time frame: When a fetal heartbeat is detected (8 weeks after implantation)

Eligibility Criteria

Female participants from 18 years up to 42 years old.

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

Additional Information

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):
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Reprogenetics.