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In Vitro Maturation With in Vitro Fertilization (IVF) Compared to Mild in Vitro Fertilization (IVM vs IVF)

Primary Purpose

Infertility

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In vitro maturation and in vitro fertilization
Low doses of gonadotropin stimulation.
Sponsored by
Batzofin Fertility Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infertility focused on measuring Polycystic ovaries,, Tubal occlusion, Unexplained infertility, Low ovarian reserve, Male factor infertility

Eligibility Criteria

21 Years - 41 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Under age 42 female, normal uterine cavity, BMI 18-34kg/m2,

Exclusion Criteria:

  • Donor eggs, donor sperm, myoma over 5 cm
  • Current hydrosalpinx, abnormal uterine cavity.

Sites / Locations

  • Batzofin Fertilty Services
  • BFS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IVM

Mild IVF

Arm Description

Early egg retrieval, in vitro maturation, then IVF

Mild gonadotropin and conventional IVF

Outcomes

Primary Outcome Measures

Cost effectiveness

Secondary Outcome Measures

Ongoing pregnancy rates per cycle

Full Information

First Posted
March 23, 2009
Last Updated
August 10, 2010
Sponsor
Batzofin Fertility Services
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1. Study Identification

Unique Protocol Identification Number
NCT00867763
Brief Title
In Vitro Maturation With in Vitro Fertilization (IVF) Compared to Mild in Vitro Fertilization
Acronym
IVM vs IVF
Official Title
Clinical Research Study on in Vitro Maturation With IVF Compared to Mild Stimulation IVF
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Suspended
Why Stopped
investigator changed location, requires new training effort
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Batzofin Fertility Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Methods of infertility treatment may involve in vitro fertilization or IVF. Though effective, IVF is complex and expensive. Methods using no gonadotropin hormone stimulation of the ovaries are being compared to mild stimulation doses. The goal of the research is to determine which of these if more suitable as a low cost approach for varying individual patients.
Detailed Description
Low cost environment is utilized, but fees are charged.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Polycystic ovaries,, Tubal occlusion, Unexplained infertility, Low ovarian reserve, Male factor infertility

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVM
Arm Type
Experimental
Arm Description
Early egg retrieval, in vitro maturation, then IVF
Arm Title
Mild IVF
Arm Type
Active Comparator
Arm Description
Mild gonadotropin and conventional IVF
Intervention Type
Procedure
Intervention Name(s)
In vitro maturation and in vitro fertilization
Other Intervention Name(s)
assisted reproduction
Intervention Description
No gonadotropin, eggs harvested early
Intervention Type
Procedure
Intervention Name(s)
Low doses of gonadotropin stimulation.
Other Intervention Name(s)
Assisted reproduction, IVF.
Intervention Description
Gonadotropin followed by conventional IVF
Primary Outcome Measure Information:
Title
Cost effectiveness
Time Frame
two years
Secondary Outcome Measure Information:
Title
Ongoing pregnancy rates per cycle
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Under age 42 female, normal uterine cavity, BMI 18-34kg/m2, Exclusion Criteria: Donor eggs, donor sperm, myoma over 5 cm Current hydrosalpinx, abnormal uterine cavity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe B Massey, MD
Organizational Affiliation
Batzofin Fertility Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Batzofin Fertilty Services
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
BFS
City
NY
State/Province
New York
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18775885
Citation
Son WY, Chung JT, Herrero B, Dean N, Demirtas E, Holzer H, Elizur S, Chian RC, Tan SL. Selection of the optimal day for oocyte retrieval based on the diameter of the dominant follicle in hCG-primed in vitro maturation cycles. Hum Reprod. 2008 Dec;23(12):2680-5. doi: 10.1093/humrep/den332. Epub 2008 Sep 4.
Results Reference
background
PubMed Identifier
18616892
Citation
Son WY, Chung JT, Demirtas E, Holzer H, Sylvestre C, Buckett W, Chian RC, Tan SL. Comparison of in-vitro maturation cycles with and without in-vivo matured oocytes retrieved. Reprod Biomed Online. 2008 Jul;17(1):59-67. doi: 10.1016/s1472-6483(10)60294-5.
Results Reference
background

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In Vitro Maturation With in Vitro Fertilization (IVF) Compared to Mild in Vitro Fertilization

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