Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency (Solaire)

Reproductive Medicine Associates of New Jersey

Status: Completed

Conditions: Infertility

Treatments: Other: Comprehensive Chromosomal Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT01977144

RMA-2013-03 (Other Identifier)

RMA1-13-290

Details and patient eligibility

About

The purpose of this study is to assess the impact of Comprehensive Chromosome Screening(CCS) on patients with low ovarian reserve in an effort to improve success during in vitro fertilization and decrease the time to successful pregnancy.

Full description

Patients will undergo a stimulated IVF cycle culminating with an ultrasound guided egg retrieval procedure and either a fresh or frozen embryo transfer as clinically appropriate and without regard to study. All embryology laboratory procedures will be conducted per routine. Once the embryo(s) have reached the blastocyst stage of development patients will be randomized into either the study group or the control group. The SOLAIRE Trial is "blinded" which means neither patients nor the RMANJ study doctor/staff will know to which group the embryos were randomized. The study group will have their embryo(s) biopsied for CCS on day 5, if appropriate, for a fresh day 6 embryo transfer. The control group will not have CCS testing performed on their embryo(s) and may proceed with a fresh or frozen embryo transfer as clinically appropriate. The maximum amount of embryos that can be transferred is two per RMANJ protocol. All post-transfer care and pregnancy monitoring will be identical and per routine protocol regardless of study participation.

Enrollment: 206 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age of female partner < 43 y/o AMH < 1.1 OR BAFC < 8 (within previous year) Male must have >100,000 motile sperm BMI < 32

Exclusion criteria

• Diagnosis of endometrial insufficiency Use of oocyte donor/gestational carriers Use of surgical sperm or DNA Banking Communicating hydosalpinges (HSG) Single gene disorders or sex selection Participation in another study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 2 patient groups

Embryo Transfer with CCS

Other group

Description:

Patients will have either a single or double embryo transfer with CCS tested embryos

Treatment:

Other: Comprehensive Chromosomal Screening

Embryo Transfer without CCS

No Intervention group

Description:

Patients in this group will not have CCS performed on their embryo(s)