Embryonic Ploidy Status in the Oncofertility Population

looking at aneuploidy rates in embryos from patients who are going to or have undergone treatment for a malignancy with gonadotoxic treatment.

Study Overview

• Status: Completed
• Conditions: Fertility; Oncology

Detailed Description

The study involves oncofertility patients--individuals who are undergoing or have undergone therapy for a malignancy--who are interested in pursuing or preserving fertility. In particular, it investigates chromosomal abnormalities or aneuploidy in the embryos of those individuals as compared to the general infertility population. Embryonic aneuploidy is largely due to reproductive senescence. As such the investigators will discuss oncofertility prevalence and treatment as well as reproductive senescence and assessment of embryonic aneuploidy. The study will seek to determine if there are changes in embryonic aneuploidy rates in oncofertility patients that differ from simple age related risks.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

oncofertility patient undergoing controlled ovarian hyperstimulation and embryo cryopreservation

Description

Inclusion Criteria:

1.Present or past oncologic diagnosis requiring potentially gonadotoxic treatment

Exclusion Criteria:

1. Oocyte banking
2. Use of oocyte donation
3. Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
4. Single gene disorder requiring more detailed embryo genetic analysis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
oncofertility patients; oncofertility patients undering controlled ovarian hyperstimulation and embryo cryopreservation who carry a present or past cancer diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
embryonic aneuploidy rates	to evaluate the incidence of embryonic aneuploidy among oncofertility patients compared to the general infertility population	1 month

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey
• Investigators: Principal Investigator: Jason Franasiak, MD, Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): March 27, 2020
• Study Completion (Actual): July 21, 2022

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: RMA-2017-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No