Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Comprehensive Chromosomal Screening

• Registration Number: NCT01977144
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-09-25
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 206

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Embryo Transfer with CCS	Comprehensive Chromosomal Screening	Patients will have either a single or double embryo transfer with CCS tested embryos

Primary Outcome Measures

Name	Time	Method
Delivery rate	2 years

Secondary Outcome Measures

Name	Time	Method
pregnancy rate per ET	2 years

Trial Locations

Locations (1)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States