Recruiting
Phase 2

NGS & ART

Sponsor:

Reprogenetics

Code:

NCT01946945

Conditions

Infertility

Recurrent Pregnancy Loss

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

Interventions

Next Generation Sequencing after Blastocyst biopsy

Study Details

Brief summary:

We propose to perform a clinical randomized trial to evaluate the effect of blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS) in comparison to standard Assisted Reproductive Technologies (ART) methods on on implantation rates, miscarriage rates, and pregnancy rates.

This will be three studies into one: a) a comparison of treatment (NGS) and no treatment, b) a non-selection study based on the control group for which we will replace without knowing the ploidy of the embryos, but we will know it later, c) a retrospective study about the use of Mitochondrial DNA as a selection tool.

Conditions

Infertility

Recurrent Pregnancy Loss

Study ID

NCT01946945

Start date

Sep, 2013

Status verified date

Sep, 2014

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients medically cleared to do a fresh or frozen embryo transfer.
  • Age up to 42 years

Exclusion Criteria:

  • microsurgical epididymal sperm aspiration (MESA) and Testicular sperm extraction (TESE) patients
  • At least one partner carrier of a chromosomal or genetic disease
  • Abnormal ovarian reserve, defined as follicle stimulating hormone (FSH) of >10 IU/L on day 2-4 of the cycle and anti-mullerian hormone (AMH) < 1ng /ml (If only one of the two parameters altered then patients is acceptable). This is based on Mandy Katz abstract at American Society for Reproductive Medicine (ASRM) 2011 where they showed that these patients have 35% chance of having no euploid embryos - They are excluded only to make the study size smaller, otherwise, if an euploid embryo is found in these patients, they implant as well as patients with normal ovarian reserve. Not all centers do AMH testing - we recommend first to run FSH and only test AMH if FSH is abnormal.
  • Egg donor cycle (sperm donor is acceptable)
  • Gender selection cycles
  • Thaw cycles

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: Control - Standard ART treatment

experimental: Test - PGS

All embryos will be hatched on day 3. Patients will have hatching blastocysts (\*) biopsied on day 5,/6. Embryos will be vitrified. Patients will have a single hatching euploid blastocyst (\*) replaced on a thawed cycle.

Interventions

Next Generation Sequencing after Blastocyst biopsy

PGD using blastocyst biopsy and testing of the biopsy by NGS

Primary outcome measure

  • improvement in ongoing implantation rates [ Time Frame: When a fetal heartbeat is detected for each patient. (8 weeks after implantation). ]

Central Contacts and Locations

Locations

Reprogenetics

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Allen Kung, BSc

973-758-7970akung@reprogenetics.com

Principal Investigator:

Santiago Munne, Ph.D

More Information

Sponsor

Reprogenetics

Last update posted

Sep 9, 2014

Last verified

Sep, 2014

Keywords

  • infertility
  • recurrent pregnancy loss
  • miscarriage
  • Next Generation Sequencing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Reprogenetics on 2014-09-09.