NCT00930501

Brief Summary

young female cancer patients have improving chances of survival. the main risk is a chronic damage to their ovarian reserve. This may lead to future infertility.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

Enrollment Period

2.5 years

First QC Date

June 28, 2009

Last Update Submit

June 29, 2009

Conditions

Infertility

Keywords

chemotherapycancerAMHgonadotoxicityovarian reservepatients exposed to chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Anti mullerian hormone

    2 years

Secondary Outcomes (5)

  • antral follicle count

    2 years

  • FSH

    2 years

  • inhibin b

    2 years

  • menstrual history

    2 years

  • E2 and prog

    2 years

Study Arms (1)

Cancer patients

women 5-45 yr olf pre and post chemotherapy

Biological: blood tests

Interventions

blood testsBIOLOGICAL

time 0 is pretreatment time 3, 6 , 9, 12 months from the end of chemotherapy

Cancer patients

Eligibility Criteria

Age5 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

females 5-45 years old

You may qualify if:

  • all females prior and after chemotherapy

You may not qualify if:

  • do not consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah

Jerusalem, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

bloods

MeSH Terms

Conditions

InfertilityNeoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Ariel Revel, MD

CONTACT

97226776424arielr2@hadassah.org.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 28, 2009

First Posted

June 30, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2013

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

IL(1)