Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency
Status: | Recruiting |
---|---|
Conditions: | Other Indications, Women's Studies, Infertility |
Therapuetic Areas: | Other, Reproductive |
Healthy: | No |
Age Range: | 18 - 43 |
Updated: | 4/6/2019 |
Start Date: | September 2013 |
End Date: | December 2020 |
Contact: | Christine V Reda, BSN, RN |
Email: | clinicalresearchteam@rmanj.com |
Phone: | 973-656-2841 |
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.
on patients with low ovarian reserve in an effort to improve success during in vitro
fertilization and decrease the time to successful pregnancy.
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.
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.
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
We found this trial at
1
site
Basking Ridge, New Jersey 07960
Principal Investigator: Richard T. Scott, MD, HCLD
Phone: 973-656-2841
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