In Vitro Maturation (IVM) of Human Oocytes
Palavras-chave
Resumo
Descrição
Natural IVF/IVM may be an attractive treatment alternative to conventional controlled ovarian hyperstimulation (COH)/IVF treatment for infertile women in particular for a select group.
Natural IVF/IVM offers several advantages over conventional COH protocols for IVF including:
1. Elimination of the need for gonadotropin ovarian stimulation
2. Elimination of risk of developing OHSS
3. Simplification of treatment, eliminating the need for frequent blood tests and ultrasound monitoring
4. Reduced cost of treatment
5. Avoiding potential side effects of gonadotropins, including weight gain, bloating, breast tenderness, nausea, mood swings
6. Eliminates concerns about the potential risk of malignancy that may be associated with multiple cycles of ovarian stimulation in a predisposed population.
This pilot study will be conducted to assess the clinical efficacy of natural IVF/IVM
datas
| Última verificação: | 10/31/2017 |
| Enviado pela primeira vez: | 04/25/2013 |
| Inscrição estimada enviada: | 04/28/2013 |
| Postado pela primeira vez: | 04/29/2013 |
| Última atualização enviada: | 11/08/2017 |
| Última atualização postada: | 11/12/2017 |
| Data real de início do estudo: | 12/31/2014 |
| Data Estimada de Conclusão Primária: | 11/30/2019 |
| Data Estimada de Conclusão do Estudo: | 11/30/2020 |
Condição ou doença
Intervenção / tratamento
Biological: IVM
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: IVM All patients registered in this study will undergo natural cycle IVF with In Vitro maturation (IVM) performed on all immature retrieved oocytes. | Biological: IVM |
Critério de eleição
| Idades qualificadas para estudar | 25 Years Para 25 Years |
| Sexos elegíveis para estudo | Female |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: 1. Each subject must be female. 2. Each subject must have an indication for COH and IVF or ICSI. 3. Each subject must be willing and able to provide written informed consent for the trial. 4. Each subject must be ≤42 years of age at the time of signing informed consent. 5. Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou [PAP] I or II) obtained within 12 months prior to signing informed consent must be available. Exclusion Criteria: 1. Subject with premature ovarian failure. 2. Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction. 3. Subject with malformation or absence of uterus. 4. Subject tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid). 5. Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone. |
Resultado
Medidas de Resultado Primário
1. Pregnancy [1 month]
2. Implantation [1 month]
3. live birth rates [9 months]
Medidas de Resultado Secundário
1. Multiple pregnancy and miscarriage rates [9 months]
2. Neonatal outcomes [9 months]
3. Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH]) [2 weeks]
4. Number and size distribution of follicles (≥11 mm, ≥15 mm, and ≥17 mm) as documented by ultrasonography during treatment [2 weeks]
5. Number and quality of oocytes retrieved [1 day]
6. Oocyte maturation rate [1 week]
7. Number of fertilized oocytes [2 days]
8. Fertilization rate [1 day]
9. Number and quality of embryos generated [1 week]
10. Endometrial thickness [2 weeks]
