ClinicalTrials.gg
CompletedNCT01977144SolaireUpdated Jan 14, 2022

Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency

An interventional study of Comprehensive Chromosomal Screening in Infertility, sponsored by Reproductive Medicine Associates of New Jersey. Completed at 1 site in United States. Open to female participants aged 18 Years to 43 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-14.

Sponsored by Reproductive Medicine Associates of New Jersey · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
18 Years to 43 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility

Keywords

  • Single Embryo Transfer
  • Double Embryo Transfer
  • CCS (Comprehensive Chromosome Screening)
  • Aneuploidy
  • Low Responders
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's enrollment of 206 is above the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Reproductive Medicine Associates of New Jersey is the lead sponsor of 55 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 43 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 \< 32

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
206 participants (actual)

Study arms

  • Other
    Embryo Transfer with CCS

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

    Other: Comprehensive Chromosomal Screening

  • No intervention
    Embryo Transfer without CCS

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

Interventions

  • OtherComprehensive Chromosomal Screening

    Also known as: PGD

06

What researchers measure

Primary outcomes

  1. Delivery rate

    Time frame: 2 years

Secondary outcomes

  1. pregnancy rate per ET

    Time frame: 2 years

07

Study locations

1 site
  • Reproductive Medicine Associates of New Jersey
    Basking Ridge, New Jersey 07920, United States
08

References and documents

Publications

  • Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3. PubMed 32898291 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01977144
Lead sponsor
Reproductive Medicine Associates of New Jersey
Responsible party
Sponsor
First posted
Nov 6, 2013
Start date
Sep 25, 2013
Primary completion
Dec 31, 2019
Completion
Jan 1, 2020
Last update
Jan 14, 2022

Study contacts

Richard T Scott, MD, HCLD
principal investigator · Reproductive Medicine Associates of New Jersey

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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