Female Patients Aged 5-35 Prior to Systemic ChemotherapyPhase 2/3HFPPNCT00578500
Fertility Preservation by Ovarian and Oocyte Cryopreservation
A Phase 2/3 study testing ovarian transplantation in people with Female Patients Aged 5-35 Prior to Systemic Chemotherapy and With Significant Risk of Ovarian Toxicity, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Success rates of cancer treatment have increased significantly resulting in many girls and young women who are treated now and will be cancer survivors. Nevertheless, cancer treatment may result in long term side effects. Damage to the ovaries may result in serious difficulty to become pregnant in the future. Read more about this study
- Who is it for?
- Ages 5 to 35 years, women only
- Conditions the study is for
- Female Patients Aged 5-35 Prior to Systemic Chemotherapy, With Significant Risk of Ovarian Toxicity
- What is being tested?
- ovarian transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2000to Jan 2010
- Phase
- Phase 2/3
- 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 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients before chemotherapy with significant risk to future fertility
Who cannot join
- high operative risk
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah University Hospital
Jerusalem, 91128
Ariel Revel, MD, 97226776424, arielr2@hadassah.org.il
Assaf Ben Meir, MD, 97226776424, assafb@hadassah.org.il
About this study
Official title: Study That Establishes the Potential of Fertility Preservation in Young Female Patients by Oocyte in Vitro Maturation and Cryopreservation and Ovarian Cortex Cryopreservation and Transplantation
Success rates of cancer treatment have increased significantly resulting in many girls and young women who are treated now and will be cancer survivors. Nevertheless, cancer treatment may result in long term side effects. Damage to the ovaries may result in serious difficulty to become pregnant in the future. The risk of this happening depends, among others upon patient's age, disease and type of treatment she undergoes. Medical research is continuously looking into ways to preserve female fertility by using less toxic protocols. Yet, keeping your eggs outside the body during treatment is an interesting option which as is routine for boys preserving sperm before cancer treatment. This research attempts to freeze eggs either in the ovarian tissue or individually.
Read the detailed description
Advances in early detection and increasing success of chemotherapy have made cancer therapy a curable disease. In children and adolescents with cancer, cure rates approach 75%. These cure rates are achieved in great part due to the use of intensive chemotherapy, and in some cases, radiation. The use of these treatment modalities is associated with significant toxicity, including the potential for gonadal damage and subsequent reduced fertility. Aggressive chemotherapy is, however, usually gonadotoxic and results in infertility in many pediatric patients. Ovarian damage is drug and dose dependant and increases with patient age at treatment. Increasing numbers of young cancer survivors are therefore experiencing infertility related to their past cancer treatment. Having children thus becomes an important issue for young cancer patients.
Cryopreservation of sperm is an effective method that is offered to pre- and post-adolescent males. Female gametes were however, not readily amenable to cryopreservation though the use of vitrification recently resulted in improved results. Nevertheless, this method is not applicable for young girls as it requires prolonged induction of ovulation and vaginal sonography to complete aspiration of oocytes. Similarly, In vitro fertilization (IVF) may be offered only to patients beyond adolescence. Ovulation induction requires a few weeks delay in the initiation of cancer treatment.
Since ovarian stimulation is generally not a feasible option for young girls and adolescents, strategies for preserving fertility in these patients usually include ovarian cryopreservation, an experimental technology with some success in animal studies, recently resulting in few deliveries following human transplantations. Although the technique remains investigational, it is being increasingly offered to women undergoing cancer treatment. In prepubertal girls ovarian cryopreservation is the only option for potentially preserving ovarian function. As we and others have shown, it is probable that methods of ovarian transplantation with vascular anastomosis will be applied in the future.
We have recently recommended that following individual consultation by a multi-disciplinary team, all female pediatric cancer patients and their families should be counseled regarding side effects of chemotherapy and be offered ovarian preservation.
The methodology of ovarian cortex preservation, pioneered by Gosden is currently routine in many centers in a few countries. Nevertheless, it is realized that the future use of this cryopreserved ovarian cortex may be limited due to cellular injury during cryopreservation and due to the tissue ischemic damage following transplantation.
Furthermore, cryobanking of ovarian cortex preserves only the smallest (primordial and primary) follicles, since all preovulatory antral follicles, which contain GV stage oocytes will not survive the procedure. We thus currently propose to all patients undergoing ovarian cryopreservation to perform integrated oocyte aspiration from antral follicles of the tissue, followed by in vitro maturation (IVM) and oocyte cryopreservation as an additional fertility-preserving method. The aim of this study was to analyze oocyte detection and IVM success rates in young girls and adolescents using this combined method.
- Conditions
- Female Patients Aged 5-35 Prior to Systemic Chemotherapy, With Significant Risk of Ovarian Toxicity
- Being tested
- ovarian transplantation
- Keywords
- chemotherapy, female, fertility preservation, gonadotoxicity, oophorectomy, in vitro maturation, ovarian cryopreservation,, oocyte cryopreservation, ovarian transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovarian transplantationProcedure or surgery
Patients will undergo laparoscopic oophorectomy, aspiration of oocytes and maturation followed by cryopreservation. In case of ovarian failure and approval by treating physicians, restoration of fertility will be attempted by thawing of oocytes or by transplantation of ovarian cortex to induce ovulation and obtain oocytes for fertilization and embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| OCCT | Active comparator | Patients referred to ovarian cryopreservation. Receives: Procedure: ovarian transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
risks involved in laparoscopic oophorectomy
Measured: 10 years
Secondary outcomes (1)
Ability to restore fertility by ovarian cortex transplantation
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startJan 2000
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Patients Aged 5-35 Prior to Systemic ChemotherapyStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Ariel Revel, MD, Principal investigator, Hadassah university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578500
- Sponsor's protocol ID
- 2819
- Other IDs
- 29-18/1/08
- Acronym
- HFPP
- Status last verified
- Jan 2002
- First submitted
- 19 Dec 2007
- Last updated
- 21 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Revel A, Koler M, Simon A, Lewin A, Laufer N, Safran A. Oocyte collection during cryopreservation of the ovarian cortex. Fertil Steril. 2003 May;79(5):1237-9. doi: 10.1016/s0015-0282(02)04963-4. No abstract available.
PubMed 12738527
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study That Establishes the Potential of Fertility Preservation in Young Female Patients by Oocyte in Vitro Maturation and Cryopreservation and Ovarian Cortex Cryopreservation and Transplantation
- ClinicalTrials.gov ID
- NCT00578500
- Acronym / sponsor ID
- HFPP / 2819
- Conditions
- Female Patients Aged 5-35 Prior to Systemic Chemotherapy, With Significant Risk of Ovarian Toxicity
- Keywords
- chemotherapy, female, fertility preservation, gonadotoxicity, oophorectomy, in vitro maturation, ovarian cryopreservation,, oocyte cryopreservation, ovarian transplantation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2000
- Study completion
- Jan 2010 (estimated)
- First posted
- 21 Dec 2007 (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.
Success rates of cancer treatment have increased significantly resulting in many girls and young women who are treated now and will be cancer survivors. Nevertheless, cancer treatment may result in long term side effects. Damage to the ovaries may result in serious difficulty to become pregnant in the future. The risk of this happening depends, among others upon patient's age, disease and type of treatment she undergoes. Medical research is continuously looking into ways to preserve female fertility by using less toxic protocols. Yet, keeping your eggs outside the body during treatment is an interesting option which as is routine for boys preserving sperm before cancer treatment. This research attempts to freeze eggs either in the ovarian tissue or individually.
Detailed description
Advances in early detection and increasing success of chemotherapy have made cancer therapy a curable disease. In children and adolescents with cancer, cure rates approach 75%. These cure rates are achieved in great part due to the use of intensive chemotherapy, and in some cases, radiation. The use of these treatment modalities is associated with significant toxicity, including the potential for gonadal damage and subsequent reduced fertility. Aggressive chemotherapy is, however, usually gonadotoxic and results in infertility in many pediatric patients. Ovarian damage is drug and dose dependant and increases with patient age at treatment. Increasing numbers of young cancer survivors are therefore experiencing infertility related to their past cancer treatment. Having children thus becomes an important issue for young cancer patients.
Cryopreservation of sperm is an effective method that is offered to pre- and post-adolescent males. Female gametes were however, not readily amenable to cryopreservation though the use of vitrification recently resulted in improved results. Nevertheless, this method is not applicable for young girls as it requires prolonged induction of ovulation and vaginal sonography to complete aspiration of oocytes. Similarly, In vitro fertilization (IVF) may be offered only to patients beyond adolescence. Ovulation induction requires a few weeks delay in the initiation of cancer treatment.
Since ovarian stimulation is generally not a feasible option for young girls and adolescents, strategies for preserving fertility in these patients usually include ovarian cryopreservation, an experimental technology with some success in animal studies, recently resulting in few deliveries following human transplantations. Although the technique remains investigational, it is being increasingly offered to women undergoing cancer treatment. In prepubertal girls ovarian cryopreservation is the only option for potentially preserving ovarian function. As we and others have shown, it is probable that methods of ovarian transplantation with vascular anastomosis will be applied in the future.
We have recently recommended that following individual consultation by a multi-disciplinary team, all female pediatric cancer patients and their families should be counseled regarding side effects of chemotherapy and be offered ovarian preservation.
The methodology of ovarian cortex preservation, pioneered by Gosden is currently routine in many centers in a few countries. Nevertheless, it is realized that the future use of this cryopreserved ovarian cortex may be limited due to cellular injury during cryopreservation and due to the tissue ischemic damage following transplantation.
Furthermore, cryobanking of ovarian cortex preserves only the smallest (primordial and primary) follicles, since all preovulatory antral follicles, which contain GV stage oocytes will not survive the procedure. We thus currently propose to all patients undergoing ovarian cryopreservation to perform integrated oocyte aspiration from antral follicles of the tissue, followed by in vitro maturation (IVM) and oocyte cryopreservation as an additional fertility-preserving method. The aim of this study was to analyze oocyte detection and IVM success rates in young girls and adolescents using this combined method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCCT | Active comparator | Procedure: ovarian transplantationPatients referred to ovarian cryopreservation. |
Who may qualify
- Ages
- 5 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients before chemotherapy with significant risk to future fertility
Key exclusion criteria (1 listed)
- high operative risk
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 |
|---|---|---|
| ovarian transplantationPatients will undergo laparoscopic oophorectomy, aspiration of oocytes and maturation followed by cryopreservation. In case of ovarian failure and approval by treating physicians, restoration of fertility will be attempted by thawing of oocytes or by transplantation of ovarian cortex to induce ovulation and obtain oocytes for fertilization and embryo transfer. | Procedure or surgery | OCCT |
Primary outcome
risks involved in laparoscopic oophorectomy
Time frame: 10 years
1 secondary outcome
Ability to restore fertility by ovarian cortex transplantation
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
- Results publication: PubMed 12738527Revel A, Koler M, Simon A, Lewin A, Laufer N, Safran A. Oocyte collection during cryopreservation of the ovarian cortex. Fertil Steril. 2003 May;79(5):1237-9. doi: 10.1016/s0015-0282(02)04963-4. No abstract available.
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.
Ariel Revel, MD principal investigator
Hadassah university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ovarian transplantation in people with Female Patients Aged 5-35 Prior to Systemic Chemotherapy and With Significant Risk of Ovarian Toxicity, 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 21 Dec 2007. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
risks involved in laparoscopic oophorectomy (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00578500, which also lists 1 linked publication.
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 21 Dec 2007.