NCT01917240

Brief Summary

To evaluate the impact of two FDA approved culture media on potential of human embryos resulting from IVF (sequential \& monophasic media). Half of each patient's embryos will be randomly assigned to grow in monophasic media \& the other half in sequential media. All embryos will undergo Comprehensive Chromosome Screening (CCS) \& the best euploid embryo from each group will be transferred resulting in a double embryo transfer (DET). If there are only euploid embryos from one group, patient will have single embryo transfer (SET)(fresh or frozen).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

2.8 years

First QC Date

July 18, 2013

Last Update Submit

June 21, 2016

Conditions

Infertility

Keywords

MonophasicSequentialMedia

Outcome Measures

Primary Outcomes (1)

  • Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates

    To assess if pregnancy rates are impacted by the type of culture media embryos produced by IVF are cultured in

    2 years

Study Arms (2)

Monophasic Media

EXPERIMENTAL

Half of each patient's embryos will be randomly assigned to grow in monophasic media \& the other half in sequential media. All embryos will undergo CCS \& the best euploid embryo from each group will be transferred (DET). If there are only euploid embryos from one group, pt will have SET only (fresh or frozen)

Other: Comprehensive Chromosome Screening

Sequential Media

PLACEBO COMPARATOR

Half of each patient's embryos will be randomly assigned to grow in monophasic media \& the other half in sequential media. All embryos will undergo CCS \& the best euploid embryo from each group will be transferred (DET). If there are only euploid embryos from one group, pt will have SET only (fresh or frozen)

Other: Comprehensive Chromosome Screening

Interventions

Comprehensive Chromosome ScreeningOTHER

On day 5 or 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS) results will be available by the morning of day 6 if embryos are suitable for a fresh transfer which is the routine in our program.

Monophasic MediaSequential Media

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient undergoing IVF/CCS (no PGD banking)
  • Patient meets ASRM guidelines for Double Embryo Transfer (DET)
  • Donor Sperm OK
  • AMH ≥ 1.2
  • FSH ≤ 12
  • BAFC ≥12
  • Max 1 prior failed IVF cycle for patients 35-45 years old
  • Patient \<35 years old MUST have 1 prior failed IVF cycle

You may not qualify if:

  • Chronic endometrial insufficiency
  • Use of oocyte donor or gestational carriers
  • Medical contraindications to Double Embryo Transfer (DET)
  • Male Factor (\<100,000 sperm or surgical sperm)
  • Communicating hydrosalpinx (on HSG)
  • Single gene disorders or sex selection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Related Publications (1)

  • Werner MD, Hong KH, Franasiak JM, Forman EJ, Reda CV, Molinaro TA, Upham KM, Scott RT Jr. Sequential versus Monophasic Media Impact Trial (SuMMIT): a paired randomized controlled trial comparing a sequential media system to a monophasic medium. Fertil Steril. 2016 May;105(5):1215-1221. doi: 10.1016/j.fertnstert.2016.01.005. Epub 2016 Jan 27.

    PMID: 26826274DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Richard T. Scott, M.D., HCLD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2013

First Posted

August 6, 2013

Study Start

July 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 22, 2016

Record last verified: 2016-06

Locations

US(1)