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

August 10, 2010 updated by: Batzofin Fertility Services

Clinical Research Study on in Vitro Maturation With IVF Compared to Mild Stimulation IVF

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Low cost environment is utilized, but fees are charged.

Study Type

Interventional

Enrollment (Anticipated)

1440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • NY, New York, United States
        • BFS
      • New York, New York, United States, 10016
        • Batzofin Fertilty Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IVM
Early egg retrieval, in vitro maturation, then IVF
Procedure: In vitro maturation and in vitro fertilization
No gonadotropin, eggs harvested early
Other Names:
  • assisted reproduction
Active Comparator: Mild IVF
Mild gonadotropin and conventional IVF
Procedure: Low doses of gonadotropin stimulation.
Gonadotropin followed by conventional IVF
Other Names:
  • Assisted reproduction, IVF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost effectiveness
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy rates per cycle
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Batzofin Fertility Services

Investigators

  • Principal Investigator: Joe B Massey, MD, Batzofin Fertility Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 23, 2009

First Posted (Estimate)

March 24, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2010

Last Update Submitted That Met QC Criteria

August 10, 2010

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2939

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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