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

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ClinicalTrials.gov Identifier: NCT01977144
Recruitment Status : Recruiting
First Posted : November 6, 2013
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

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.

Condition or disease Intervention/treatment Phase
Infertility Other: Comprehensive Chromosomal Screening Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency
Study Start Date : September 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Embryo Transfer with CCS
Patients will have either a single or double embryo transfer with CCS tested embryos
Other: Comprehensive Chromosomal Screening
Other Name: PGD

No Intervention: Embryo Transfer without CCS
Patients in this group will not have CCS performed on their embryo(s)



Primary Outcome Measures :
  1. Delivery rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. pregnancy rate per ET [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977144


Contacts
Contact: Christine V Reda, BSN, RN 973-656-2841 clinicalresearchteam@rmanj.com
Contact: Talia Metzgar, RN 973-656-2841 clinicalresearchteam@rmanj.com

Locations
United States, New Jersey
Reproductive Medicine Associates of New Jersey Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Christine V. Reda, BSN, RN    973-656-2841    clinicalresearchteam@rmanj.com   
Principal Investigator: Richard T. Scott, MD, HCLD         
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Richard T Scott, MD, HCLD Reproductive Medicine Associates of New Jersey

Additional Information:
Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01977144     History of Changes
Other Study ID Numbers: RMA1-13-290
RMA-2013-03 ( Other Identifier: RMANJ )
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Reproductive Medicine Associates of New Jersey:
Single Embryo Transfer
Double Embryo Transfer
CCS (Comprehensive Chromosome Screening)
Aneuploidy
Low Responders

Additional relevant MeSH terms:
Infertility
Aneuploidy
Genital Diseases, Male
Genital Diseases, Female
Chromosome Aberrations
Pathologic Processes