In Vitro Maturation (IVM) of Human Oocytes

Northwell Health

Status: Withdrawn

Conditions: Ovarian Hyper Stimulation Syndrome (OHSS); Patients Sensitive to Exogenous Gonadotropins; Polycystic Ovarian Syndrome (PCOS)

Treatments: Biological: In Vitro maturation

Study type: Interventional

Funder types: Other

Identifiers

NCT01843569

12-364A

Details and patient eligibility

About

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.

Full 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

Sex: Female

Ages: 25 to 42 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

IVM

Experimental group

Description:

All patients registered in this study will undergo natural cycle IVF with In Vitro maturation (IVM) performed on all immature retrieved oocytes.

Treatment:

Biological: In Vitro maturation