Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency (Solaire)
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Chromosomal Screening
Sponsored by
About this trial
This is an interventional other trial for Infertility focused on measuring Single Embryo Transfer, Double Embryo Transfer, CCS (Comprehensive Chromosome Screening), Aneuploidy, Low Responders
Eligibility 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
Sites / Locations
- Reproductive Medicine Associates of New Jersey
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Embryo Transfer with CCS
Embryo Transfer without CCS
Arm Description
Patients will have either a single or double embryo transfer with CCS tested embryos
Patients in this group will not have CCS performed on their embryo(s)
Outcomes
Primary Outcome Measures
Delivery rate
Secondary Outcome Measures
pregnancy rate per ET
Full Information
NCT ID
NCT01977144
First Posted
October 24, 2013
Last Updated
January 13, 2022
Sponsor
Reproductive Medicine Associates of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT01977144
Brief Title
Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency
Acronym
Solaire
Official Title
Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2013 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive Medicine Associates of New Jersey
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Single Embryo Transfer, Double Embryo Transfer, CCS (Comprehensive Chromosome Screening), Aneuploidy, Low Responders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Embryo Transfer with CCS
Arm Type
Other
Arm Description
Patients will have either a single or double embryo transfer with CCS tested embryos
Arm Title
Embryo Transfer without CCS
Arm Type
No Intervention
Arm Description
Patients in this group will not have CCS performed on their embryo(s)
Intervention Type
Other
Intervention Name(s)
Comprehensive Chromosomal Screening
Other Intervention Name(s)
PGD
Primary Outcome Measure Information:
Title
Delivery rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
pregnancy rate per ET
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard T Scott, MD, HCLD
Organizational Affiliation
Reproductive Medicine Associates of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Medicine Associates of New Jersey
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32898291
Citation
Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
Results Reference
derived
Links:
URL
http://www.rmanj.com
Description
RMA of NJ
Learn more about this trial
Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency
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