- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00578500
Fertility Preservation by Ovarian and Oocyte Cryopreservation (HFPP)
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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Studijní místa
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Jerusalem, Izrael, 91128
- Nábor
- Hadassah University Hospital
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Kontakt:
- Assaf Ben Meir, MD
- Telefonní číslo: 97226776424
- E-mail: assafb@hadassah.org.il
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- patients before chemotherapy with significant risk to future fertility
Exclusion Criteria:
- high operative risk
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: OCCT
Patients referred to ovarian cryopreservation.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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risks involved in laparoscopic oophorectomy
Časové okno: 10 years
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10 years
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Ability to restore fertility by ovarian cortex transplantation
Časové okno: 10 years
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10 years
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Ariel Revel, MD, Hadassah University Hospital
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2819
- 29-18/1/08
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