InfertilityOvrescancerNCT00930501
Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients
An observational study of Infertility, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- blood tests
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: females 5-45 years old
Who may be able to join
- all females prior and after chemotherapy
Who cannot join
- do not consent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah
Jerusalem
Ariel Revel, MD, 97226776424, arielr2@hadassah.org.il
Ariel Revel, MD
About this study
Official title: Phase 1 Prospective Study of Markers of Ovarian Reserve in Young Female Cancer Patients
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.
Read the detailed description
our objective is to prospectively follow patients before and after their cancer treatment. this should help us learn of the gonadotoxicity of various treatments as well as be able to better consult these and future patients of the need of fertility preservation techniques.
- Conditions
- Infertility
- Being tested
- blood tests
- Keywords
- chemotherapy, cancer, AMH, gonadotoxicity, ovarian reserve, patients exposed to chemotherapy
- Medical subject headings
- Infertility, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testsBiological
time 0 is pretreatment time 3, 6 , 9, 12 months from the end of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | women 5-45 yr olf pre and post chemotherapy Receives: Biological: blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti mullerian hormone
Measured: 2 years
Secondary outcomes (5)
antral follicle count
Measured: 2 years
FSH
Measured: 2 years
inhibin b
Measured: 2 years
menstrual history
Measured: 2 years
E2 and prog
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930501
- Sponsor's protocol ID
- 111222
- Acronym
- Ovrescancer
- Status last verified
- Jun 2009
- First submitted
- 28 Jun 2009
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Prospective Study of Markers of Ovarian Reserve in Young Female Cancer Patients
- ClinicalTrials.gov ID
- NCT00930501
- Acronym / sponsor ID
- Ovrescancer / 111222
- Conditions
- Infertility
- Keywords
- chemotherapy, cancer, AMH, gonadotoxicity, ovarian reserve, patients exposed to chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
our objective is to prospectively follow patients before and after their cancer treatment. this should help us learn of the gonadotoxicity of various treatments as well as be able to better consult these and future patients of the need of fertility preservation techniques.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | Biological: blood testswomen 5-45 yr olf pre and post chemotherapy |
Who may qualify
- Ages
- 5 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- females 5-45 years old
Key inclusion criteria (1 listed)
- all females prior and after chemotherapy
Key exclusion criteria (1 listed)
- do not consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood teststime 0 is pretreatment time 3, 6 , 9, 12 months from the end of chemotherapy | Biological | Cancer patients |
Primary outcome
Anti mullerian hormone
Time frame: 2 years
5 secondary outcomes
antral follicle count
Time frame: 2 years
FSH
Time frame: 2 years
inhibin b
Time frame: 2 years
menstrual history
Time frame: 2 years
E2 and prog
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariel Revel, MD (97226776424, arielr2@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti mullerian hormone (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2009.