Fertility Preservation by Ovarian and Oocyte Cryopreservation (HFPP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2002 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00578500
First received: December 19, 2007
Last updated: NA
Last verified: January 2002
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Female Patients Aged 5-35 Prior to Systemic Chemotherapy
With Significant Risk of Ovarian Toxicity
Procedure: ovarian transplantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • risks involved in laparoscopic oophorectomy [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ability to restore fertility by ovarian cortex transplantation [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2000
Estimated Study Completion Date: January 2010
Arms Assigned Interventions
Active Comparator: OCCT
Patients referred to ovarian cryopreservation.
Procedure: ovarian transplantation
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients before chemotherapy with significant risk to future fertility

Exclusion Criteria:

  • high operative risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578500

Contacts
Contact: Ariel Revel, MD 97226776424 arielr2@hadassah.org.il
Contact: Assaf Ben Meir, MD 97226776424 AssafB@hadassah.org.il

Locations
Israel
Hadassah University Hospital Recruiting
Jerusalem, Israel, 91128
Contact: Ariel Revel, MD    97226776424    arielr2@hadassah.org.il   
Contact: Assaf Ben Meir, MD    97226776424    assafb@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ariel Revel, MD Hadassah university hospital
  More Information

Publications:
Responsible Party: Ariel Revel, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00578500     History of Changes
Other Study ID Numbers: 2819, 29-18/1/08
Study First Received: December 19, 2007
Last Updated: December 19, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
chemotherapy, female, fertility preservation, gonadotoxicity
oophorectomy, in vitro maturation, ovarian cryopreservation,
oocyte cryopreservation, ovarian transplantation

ClinicalTrials.gov processed this record on October 21, 2014