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Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency

Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01977144
Acronym
Solaire
Enrollment
206
Registered
2013-11-06
Start date
2013-09-25
Completion date
2020-01-01
Last updated
2022-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Single Embryo Transfer, Double Embryo Transfer, CCS (Comprehensive Chromosome Screening), Aneuploidy, Low Responders

Brief summary

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.

Detailed 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.

Interventions

OTHERComprehensive Chromosomal Screening

Sponsors

Reproductive Medicine Associates of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Delivery rate2 years

Secondary

MeasureTime frame
pregnancy rate per ET2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026