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N/A
25 Years
42 Years
Not Enrolling
Female
Polycystic Ovarian Syndrome (PCOS), Patients Sensitive to Exogenous Gonadotropins, Ovarian Hyper Stimulation Syndrome (OHSS)

Thank you

Trial Information


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pregnancy

Outcome Description:

Establishment of a successful pregnancy

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Avner Hershlag, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSLIJ

Authority:

United States: Institutional Review Board

Study ID:

In Vitro maturation

NCT ID:

NCT01843569

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Polycystic Ovarian Syndrome (PCOS)
  • Patients Sensitive to Exogenous Gonadotropins
  • Ovarian Hyper Stimulation Syndrome (OHSS)
  • In Vitro Maturation
  • IVM
  • Natural cycle IVF
  • PCOS
  • Polycystic Ovary Syndrome
  • Ovarian Hyperstimulation Syndrome

Name

Location
The Center for Human Reproduction Manhasset, New York  11030