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OpenTrials
Completed

NCT Number: NCT00799929

IVF Clinical Trial of Two Different Treatment Protocols.

The purpose of this study is to compare two different in vitro fertilization (IVF) treatments: conventional IVF protocol and minimal stimulation IVF protocol, in terms of success rates, stress of treatment, drug-related side effects, multiple pregnancies and cost of treatment.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New Hope Fertility Center

New York, 10021, United States

About this study

A random population of 564 sub-fertile women or couples with a female between ages of 18 and 38 years and a desire to undergo their first IVF cycle will be included in this outpatient clinical trial. The participation in this study will be approximately six months with a total of 20 to 25 visits. After successful completion of the pre-screening tests participants are randomized into one of the two arms of the study: Arm A - mini IVF protocol, and Arm B - conventional IVF protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Valid indication for IVF treatment
  • First IVF attempt
  • Female age between 18 and 38 years
  • Male partner 18 years of age or older
  • Both partners STD free
  • Must be able to understand that they may NOT become pregnant

Exclusion criteria

  • Not willing or able to sign the consent form
  • Pre-existing medical condition preventing/interfering with IVF treatment
  • Abnormal IVF screening tests, which includes Complete Blood Count, Varicella titer, Rubella titer, PAP smear, Syphilis, HIV 1&2, Hepatitis B, Hepatitis C, Chlamydia, and Gonorrhea
  • Abnormal pap smear
  • Body Mass Index (BMI) falls below 18.5 or above 32.0
  • Female participant with irregular menstrual cycles

Treatment and study plan

in vitro fertilization (IVF/ICSI)

Other

Primary outcomes

  1. Primary outcome parameter: Live birth

    Time frame: 4 Years

Secondary outcomes

  1. Secondary outcome parameters: Biochemical pregnancy, Clinical pregnancy, Ongoing pregnancy, Multiple pregnancy rate, Miscarriage rate, Fertilization rate, Number of oocytes, Number of embryos

    Time frame: 4 Years

Sponsors and collaborators

Lead sponsor

New Hope Fertility Center

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Registry information

Official study title

Efficiency and Patient Satisfaction of Two Different IVF Protocols.

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 1, 2008
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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