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

Primary Purpose

Infertility

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
in vitro maturation
Polar Body Biopsy with preimplantation genetic screening
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring infertility, in vitro maturation (IVM), in vitro fertilization (IVF), natural cycle

Eligibility Criteria

25 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Each subject must be female.
  2. Each subject must have an indication for COH and IVF with or without ICSI.
  3. Each subject must be willing and able to provide written informed consent for the trial
  4. Each subject must be 25 to ≤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 has 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

Sites / Locations

  • Center for Reproductive Medicine- Weill Cornell Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

In vitro Maturation

Arm Description

in vitro maturation of immature oocytes

Outcomes

Primary Outcome Measures

number of oocytes retrieved and embryos generated

Secondary Outcome Measures

live birth rate

Full Information

First Posted
February 16, 2012
Last Updated
November 18, 2022
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01550861
Brief Title
In Vitro Maturation (IVM) of Human Oocytes
Acronym
IVM
Official Title
In Vitro Maturation (IVM) of Human Oocytes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2012 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study are to evaluate the clinical efficacy of Natural in vitro Fertilization and in vitro maturation.
Detailed Description
Collection of one mature egg from a follicle in the ovary without gonadotropin medications (natural cycle IVF) results in low pregnancy rates. One way to improve natural cycle IVF is to combine this procedure with the removal of immature eggs from the ovary and mature these eggs in the laboratory ( in vitro maturation-IVM). The in vitro mature eggs are fertilized and the resultant embryos are cultured using conventional IVF techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility, in vitro maturation (IVM), in vitro fertilization (IVF), natural cycle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In vitro Maturation
Arm Type
Experimental
Arm Description
in vitro maturation of immature oocytes
Intervention Type
Procedure
Intervention Name(s)
in vitro maturation
Intervention Description
Maturation of immature oocytes in the laboratory following oocyte retrieval
Intervention Type
Procedure
Intervention Name(s)
Polar Body Biopsy with preimplantation genetic screening
Intervention Description
Polar body biopsy is performed on the day that the oocyte is retrieved. Microarray analysis will will be performed and compared with FISH and microarray analysis of day 3 or day 5 biopsy.
Primary Outcome Measure Information:
Title
number of oocytes retrieved and embryos generated
Time Frame
1 year
Secondary Outcome Measure Information:
Title
live birth rate
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Each subject must be female. Each subject must have an indication for COH and IVF with or without ICSI. Each subject must be willing and able to provide written informed consent for the trial Each subject must be 25 to ≤42 years of age at the time of signing informed consent. 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: Subject with premature ovarian failure Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction Subject with malformation or absence of uterus Subject has 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). Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodriq Stubbs, NP
Phone
646-962-3276
Email
res2011@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mitasha Joseph, RN, MPA
Phone
646-962-3382
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zev Rosenwaks, MD
Organizational Affiliation
Weill Cornell
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Reproductive Medicine- Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodriq Stubbs, NP
Phone
646-962-3276
Email
res2011@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Mitasha Joseph, RN, MPA
Phone
646-962-3382
First Name & Middle Initial & Last Name & Degree
Zev Rosenwaks, MD

12. IPD Sharing Statement

Links:
URL
http://ivf.org
Description
Center for Reproductive Medicine- Weill Cornell Medical College

Learn more about this trial

In Vitro Maturation (IVM) of Human Oocytes

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