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In Vitro Maturation (IVM) of Human Oocytes (IVM)

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ClinicalTrials.gov Identifier: NCT01843569
Recruitment Status : Withdrawn (Institutional approval of study has expired.)
First Posted : April 30, 2013
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Northwell Health

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome (PCOS) Patients Sensitive to Exogenous Gonadotropins Ovarian Hyper Stimulation Syndrome (OHSS) Biological: In Vitro maturation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In Vitro Maturation (IVM) of Human Oocytes
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: In Vitro maturation



Primary Outcome Measures :
  1. Pregnancy [ Time Frame: 1 month ]
    Establishment of a successful pregnancy

  2. Implantation [ Time Frame: 1 month ]
    fetal hearts per embryo replaced

  3. live birth rates [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Multiple pregnancy and miscarriage rates [ Time Frame: 9 months ]
  2. Neonatal outcomes [ Time Frame: 9 months ]
  3. Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH]) [ Time Frame: 2 weeks ]
  4. Number and size distribution of follicles (≥11 mm, ≥15 mm, and ≥17 mm) as documented by ultrasonography during treatment [ Time Frame: 2 weeks ]
  5. Number and quality of oocytes retrieved [ Time Frame: 1 day ]
  6. Oocyte maturation rate [ Time Frame: 1 week ]
  7. Number of fertilized oocytes [ Time Frame: 2 days ]
  8. Fertilization rate [ Time Frame: 1 day ]
  9. Number and quality of embryos generated [ Time Frame: 1 week ]
  10. Endometrial thickness [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   25 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843569


Locations
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United States, New York
The Center for Human Reproduction
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Avner Hershlag, MD NSLIJ
Publications:
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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01843569    
Other Study ID Numbers: 12-364A
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Keywords provided by Northwell Health:
In Vitro Maturation
IVM
Natural cycle IVF
PCOS
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Hyperstimulation Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases