Ovarian Freezing Before Cancer Treatment | NCT01057745

Studies
Ovarian Freezing Before Cancer Treatment

NCT01057745

Sponsor

University of Pennsylvania

Status

Terminated

Last Update Posted

Apr 15, 2021Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Effects of Chemotherapy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This treatment is now considered standard of care

Expanded Access Info

Start Date

Jun 12, 2007Actual

Primary Completion Date

Mar 31, 2020Actual

Completion Date

Mar 31, 2020Actual

First Submitted Date

Jan 26, 2010

First Submission Date that Met QC Criteria

Jan 26, 2010

First Posted Date

Jan 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2021

Last Update Posted Date

Apr 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Women of reproductive age who will undergo cancer treatment may participate in a study to surgically remove ovarian tissue and store it, frozen, for their potential use in the future. 20% of collected tissue will be used for research.

Detailed Description

Chemotherapy and radiation therapy for cancer can compromise the ability to become pregnant. Experiments in animals and humans have tried to collect, freeze and store eggs to see if they can be saved for possible later use. While studies are promising, it is still uncertain whether such approaches will ultimately prove to be useful in practice for achieving pregnancy in humans. The main purpose of this study is to see whether it is possible to remove and store ovarian tissues by freezing. It is hoped that, in the future, frozen, stored ovarian tissue can be used to achieve pregnancy. Before receiving chemotherapy or radiation therapy, subjects will have a piece of the ovaries, or one of two ovaries, removed by surgery. The tissues will be frozen by a special method in an effort to prevent the eggs from being damaged. The majority (80%) of the tissue will be stored for potential use in case the patient is unable to achieve pregnancy in the future, and part of the tissue (20%) will be used for studying how the eggs can be grown in the laboratory.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

31Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Follicular development in vitro	Several factors, including 3-dimensional biogel scaffolds,growth factors, hormones and other culture conditions, will be investigated as they relate to successful maturation of immature follicles obtained from ovarian tissue.	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female patient between the ages of 18 and 42 years.
In need of imminent cancer treatment, including surgery, chemotherapy or radiation therapy, which is viewed as likely to result in a permanent and complete loss of subsequent ovarian function or have a health condition that will result in premature ovarian failure. These include, but are not limited to: abdominopelvic irradiation, total body irradiation, alkylating-intensive chemotherapy, and removal of ovaries as part of their cancer treatment.
Reasonably good health.
Two ovaries.
Able to defer definitive cancer therapy for approximately 3 days until the patient recovers from laparoscopic oophorectomy.

Exclusion Criteria:

Patients considered as high risk for surgical complications will be excluded from the research protocol.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clarisa Gracia, MD, MSCE	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Penn Fertility Care, 3701 Market Street, Suite 800		Philadelphia	Pennsylvania	19104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22466745	Background	Gracia CR, Chang J, Kondapalli L, Prewitt M, Carlson CA, Mattei P, Jeffers S, Ginsberg JP. Ovarian tissue cryopreservation for fertility preservation in cancer patients: successful establishment and feasibility of a multidisciplinary collaboration. J Assist Reprod Genet. 2012 Jun;29(6):495-502. doi: 10.1007/s10815-012-9753-7. Epub 2012 Apr 1.