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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03350230
Other study ID # RMA-2017-05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date July 21, 2022

Study information

Verified date May 2023
Source Reproductive Medicine Associates of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 21, 2022
Est. primary completion date March 27, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Reproductive Medicine Associates of New Jersey Basking Ridge New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary embryonic aneuploidy rates to evaluate the incidence of embryonic aneuploidy among oncofertility patients compared to the general infertility population 1 month
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