Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency
Solaire
2 other identifiers
interventional
206
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 25, 2013
CompletedFirst Submitted
Initial submission to the registry
October 24, 2013
CompletedFirst Posted
Study publicly available on registry
November 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJanuary 14, 2022
January 1, 2022
6.3 years
October 24, 2013
January 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delivery rate
2 years
Secondary Outcomes (1)
pregnancy rate per ET
2 years
Study Arms (2)
Embryo Transfer with CCS
OTHERPatients will have either a single or double embryo transfer with CCS tested embryos
Embryo Transfer without CCS
NO INTERVENTIONPatients in this group will not have CCS performed on their embryo(s)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920, United States
Related Publications (1)
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.
PMID: 32898291DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard T Scott, MD, HCLD
Reproductive Medicine Associates of New Jersey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2013
First Posted
November 6, 2013
Study Start
September 25, 2013
Primary Completion
December 31, 2019
Study Completion
January 1, 2020
Last Updated
January 14, 2022
Record last verified: 2022-01