Fertility Preservation by Ovarian and Oocyte Cryopreservation (HFPP)
|ClinicalTrials.gov Identifier: NCT00578500|
Recruitment Status : Unknown
Verified January 2002 by Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : December 21, 2007
Last Update Posted : December 21, 2007
|Condition or disease||Intervention/treatment||Phase|
|Female Patients Aged 5-35 Prior to Systemic Chemotherapy With Significant Risk of Ovarian Toxicity||Procedure: ovarian transplantation||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2000|
|Estimated Study Completion Date :||January 2010|
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.
- risks involved in laparoscopic oophorectomy [ Time Frame: 10 years ]
- Ability to restore fertility by ovarian cortex transplantation [ Time Frame: 10 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578500
|Contact: Ariel Revel, MDfirstname.lastname@example.org|
|Contact: Assaf Ben Meir, MD||97226776424||AssafB@hadassah.org.il|
|Hadassah University Hospital||Recruiting|
|Jerusalem, Israel, 91128|
|Contact: Ariel Revel, MD 97226776424 email@example.com|
|Contact: Assaf Ben Meir, MD 97226776424 firstname.lastname@example.org|
|Principal Investigator:||Ariel Revel, MD||Hadassah university hospital|