NCT02515916

Brief Summary

The purpose of this study is assess the effects of oncology treatment on ovarian reserve and also to better understand the experiences, thoughts and feelings of women scheduled to undergo chemotherapy/radiotherapy and seeking fertility preservation at Weill Cornell Medical College (WCMC).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 9, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

3.8 years

First QC Date

July 9, 2015

Last Update Submit

October 27, 2021

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

  • AMH (anti-mullerian hormone) blood levels

    To determine if fertility reserve is affected by oncology treatment.

    Up to 3 years

  • Quality of life on the Dyadic Adjustment Scale

    To determine if there is any psychological impact of oncology treatment.

    3 years

Interventions

Not InterventionalOTHER

This will be a prospective, non-randomized, uncontrolled study examining the effects of oncology treatments in women at risk for treatment induced ovarian failure.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women scheduled to undergo chemotherpay/radiotherapy and are seeking fertility preservation at WCMC

You may qualify if:

  • Women ages 18-45
  • Women seeking fertility preservation at WCMC
  • Women who will undergo oncology treatments that will likely cause reduced fertility potential.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ronald O. Perelmand and Claudia Cohen Center for Reproductive Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Glenn Schattman, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2015

First Posted

August 5, 2015

Study Start

May 30, 2017

Primary Completion

March 12, 2021

Study Completion

March 12, 2021

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)