Ovarian Hyper Stimulation Syndrome (OHSS), Patients Sensitive to Exogenous Gonadotropins, Polycystic Ovarian Syndrome (PCOS)
Conditions
Keywords
In Vitro Maturation, IVM, Natural cycle IVF, PCOS
Brief summary
We hypothesize that the combination of natural cycle IVF or low dose gonadotropin injection combined with In Vitro Maturation (IVM) (Natural IVF/IVM) is a viable option for a selected population of infertility patients who cannot tolerate exogenous gonadotropins or are at risk of ovarian hyperstimulation syndrome.
Detailed description
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
Interventions
BIOLOGICALIn Vitro maturation
Sponsors
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 42 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | 1 month | Establishment of a successful pregnancy |
| Implantation | 1 month | fetal hearts per embryo replaced |
| live birth rates | 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH]) | 2 weeks |
| Number and size distribution of follicles (≥11 mm, ≥15 mm, and ≥17 mm) as documented by ultrasonography during treatment | 2 weeks |
| Number and quality of oocytes retrieved | 1 day |
| Endometrial thickness | 2 weeks |
| Number of fertilized oocytes | 2 days |
| Fertilization rate | 1 day |
| Number and quality of embryos generated | 1 week |
| Oocyte maturation rate | 1 week |
| Multiple pregnancy and miscarriage rates | 9 months |
| Neonatal outcomes | 9 months |
Countries
United States
Outcome results
None listed