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NCT01977144 Clinical Trial

Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency

Infertility Clinical Trial

— Solaire  

Official title:
Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01977144
Other study ID # RMA1-13-290
Secondary ID RMA-2013-03
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2013
Est. completion date January 1, 2020

Study information
Verified date January 2022
Source Reproductive Medicine Associates of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 206
Est. completion date January 1, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 43 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Comprehensive Chromosomal Screening

Locations
Country Name City State
United States Reproductive Medicine Associates of New Jersey Basking Ridge New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Delivery rate 2 years
Secondary pregnancy rate per ET 2 years
See also
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Completed NCT03623659 - pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts N/A
Completed NCT03895099 - New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors Phase 3
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Completed NCT04108039 - Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles. N/A
Completed NCT03678818 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA) N/A
Completed NCT03678597 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB) N/A
Completed NCT03678584 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA) N/A
Completed NCT03678610 - Handling Medium for ICSI With Ionomycin and Latrunculin A N/A
Completed NCT03677492 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD) N/A
Completed NCT03678558 - Oocyte Vitrification Aided With Cytochalasin B N/A
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