Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-25

Study Completion Date

2020-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Embryo Transfer with CCS

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

Group Type OTHER

Comprehensive Chromosomal Screening

Intervention Type OTHER

Embryo Transfer without CCS

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Comprehensive Chromosomal Screening

Intervention Type OTHER

Other Intervention Names

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PGD

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes