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

Primary Purpose

Polycystic Ovarian Syndrome (PCOS), Patients Sensitive to Exogenous Gonadotropins, Ovarian Hyper Stimulation Syndrome (OHSS)

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

In Vitro maturation

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome (PCOS) focused on measuring In Vitro Maturation, IVM, Natural cycle IVF, PCOS

Eligibility Criteria

25 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Each subject must be female.
Each subject must have an indication for COH and IVF or ICSI.
Each subject must be willing and able to provide written informed consent for the trial.
Each subject must be ≤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 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.

Sites / Locations

The Center for Human Reproduction

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IVM

Arm Description

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

Outcomes

Primary Outcome Measures

Pregnancy

Establishment of a successful pregnancy

Implantation

fetal hearts per embryo replaced

live birth rates

Secondary Outcome Measures

Multiple pregnancy and miscarriage rates

Neonatal outcomes

Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH])

Number and size distribution of follicles (≥11 mm, ≥15 mm, and ≥17 mm) as documented by ultrasonography during treatment

Number and quality of oocytes retrieved

Oocyte maturation rate

Number of fertilized oocytes

Fertilization rate

Number and quality of embryos generated

Endometrial thickness

Full Information

NCT ID

NCT01843569

First Posted

April 26, 2013

Last Updated

November 12, 2020

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT01843569

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 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Institutional approval of study has expired.

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwell Health

4. Oversight

Data Monitoring Committee

5. Study Description

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: Elimination of the need for gonadotropin ovarian stimulation Elimination of risk of developing OHSS Simplification of treatment, eliminating the need for frequent blood tests and ultrasound monitoring Reduced cost of treatment Avoiding potential side effects of gonadotropins, including weight gain, bloating, breast tenderness, nausea, mood swings 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovarian Syndrome (PCOS), Patients Sensitive to Exogenous Gonadotropins, Ovarian Hyper Stimulation Syndrome (OHSS)

Keywords

In Vitro Maturation, IVM, Natural cycle IVF, PCOS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IVM

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

In Vitro maturation

Primary Outcome Measure Information:

Title

Pregnancy

Description

Establishment of a successful pregnancy

Time Frame

1 month

Title

Implantation

Description

fetal hearts per embryo replaced

Time Frame

1 month

Title

live birth rates

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Multiple pregnancy and miscarriage rates

Time Frame

9 months

Title

Neonatal outcomes

Time Frame

9 months

Title

Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH])

Time Frame

2 weeks

Title

Number and size distribution of follicles (≥11 mm, ≥15 mm, and ≥17 mm) as documented by ultrasonography during treatment

Time Frame

2 weeks

Title

Number and quality of oocytes retrieved

Time Frame

1 day

Title

Oocyte maturation rate

Time Frame

1 week

Title

Number of fertilized oocytes

Time Frame

2 days

Title

Fertilization rate

Time Frame

1 day

Title

Number and quality of embryos generated

Time Frame

1 week

Title

Endometrial thickness

Time Frame

2 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Each subject must be female. Each subject must have an indication for COH and IVF or ICSI. Each subject must be willing and able to provide written informed consent for the trial. Each subject must be ≤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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Avner Hershlag, MD

Organizational Affiliation

NSLIJ

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Center for Human Reproduction

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

12. IPD Sharing Statement

Citations:

Citation

Practice Committee of the American Society for Reproductive Medicine (ASRM). Committee opinion: In Vitro Maturation. Fertil & Steril. Ready for member review 2/21/12. Not yet in print.

Results Reference

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PubMed Identifier

15528263

Citation

Le Du A, Kadoch IJ, Bourcigaux N, Doumerc S, Bourrier MC, Chevalier N, Fanchin R, Chian RC, Tachdjian G, Frydman R, Frydman N. In vitro oocyte maturation for the treatment of infertility associated with polycystic ovarian syndrome: the French experience. Hum Reprod. 2005 Feb;20(2):420-4. doi: 10.1093/humrep/deh603. Epub 2004 Nov 4.

Results Reference

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PubMed Identifier

14989791

Citation

Chian RC, Buckett WM, Tan SL. In-vitro maturation of human oocytes. Reprod Biomed Online. 2004 Feb;8(2):148-66. doi: 10.1016/s1472-6483(10)60511-1.

Results Reference

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PubMed Identifier

16996508

Citation

Jurema MW, Nogueira D. In vitro maturation of human oocytes for assisted reproduction. Fertil Steril. 2006 Nov;86(5):1277-91. doi: 10.1016/j.fertnstert.2006.02.126. Epub 2006 Sep 25.

Results Reference

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PubMed Identifier

17906024

Citation

Buckett WM, Chian RC, Holzer H, Dean N, Usher R, Tan SL. Obstetric outcomes and congenital abnormalities after in vitro maturation, in vitro fertilization, and intracytoplasmic sperm injection. Obstet Gynecol. 2007 Oct;110(4):885-91. doi: 10.1097/01.AOG.0000284627.38540.80.

Results Reference

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In Vitro Maturation (IVM) of Human Oocytes

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