Sequential vs. Monophasic Media Impact Trial (SuMMIT)

Phase 4

Completed

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

• Registration Number: NCT01917240
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-06
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monophasic Media	Comprehensive Chromosome Screening	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)
Sequential Media	Comprehensive Chromosome Screening	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)

Primary Outcome Measures

Name	Time	Method
Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates	2 years	To assess if pregnancy rates are impacted by the type of culture media embryos produced by IVF are cultured in

Trial Locations

Locations (1)

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