Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency

Study Overview
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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.

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.

Official Title
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Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency

Conditions
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Infertility

Intervention / Treatment
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* Other: Comprehensive Chromosomal Screening


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Embryo Transfer with CCS<br>Patients will have either a single or double embryo transfer with CCS tested embryos | Other: Comprehensive Chromosomal Screening<br> <br> * Other names: PGD;|
| No Intervention: Embryo Transfer without CCS<br>Patients in this group will not have CCS performed on their embryo(s) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate per ET |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single Embryo Transfer, Double Embryo Transfer, CCS (Comprehensive Chromosome Screening), Aneuploidy, Low Responders