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IVF Clinical Trial of Two Different Treatment Protocols.

This study is currently recruiting participants.
Verified October 2012 by New Hope Fertility Center
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
New York Downtown Hospital
Information provided by (Responsible Party):
New Hope Fertility Center
ClinicalTrials.gov Identifier:
NCT00799929
First received: November 26, 2008
Last updated: October 25, 2012
Last verified: October 2012
History of Changes

November 26, 2008
October 25, 2012
December 2008
June 2013   (final data collection date for primary outcome measure)
Primary outcome parameter: Live birth [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]
The primary outcome is to determine which of these studied methods should be applied routinely to all IVF patients. [ Time Frame: two years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00799929 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
To determine which methods has better results in terms of live birth rate, costs of treatment, which is more patient-friendly including reducing the stress of treatment, administration of drugs and reducing multiple pregnancies. [ Time Frame: two years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
IVF Clinical Trial of Two Different Treatment Protocols.
Efficiency and Patient Satisfaction of Two Different IVF 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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
Other: in vitro fertilization (IVF/ICSI)
  • Active Comparator: ARM A - Mini IVF
    The Mini IVF method entails pre-treatment with oral contraceptive pills. Ovarian stimulation is achieved using an oral anti-estrogen in conjunction with injections of gonadotropin (225IU-600IU per cycle), with initial dose of 75IU-150IU per injection. Ovulation is induced by a GnRH (gonadotropin-releasing hormone) agonist nasal spray/hCG (human chorionic gonadotropin) injection. Retrieved oocytes following in vitro fertilization (IVF/ICSI) are cultured to the blastocyst stage. Blastocyst stage embryos are vitrified using the CryoTop method. No fresh embryo transfer is conducted. Subsequently, SET of a thawed blastocyst is performed in a natural cycle/HRT that does not involve ovarian stimulation. SETs are conducted until pregnancy is achieved or all vitrified blastocysts have been used.
    Intervention: Other: in vitro fertilization (IVF/ICSI)
  • Active Comparator: Arm B - Conventional IVF
    The standard IVF method entails pre-treatment with a GnRH analog injections in the midluteal phase. Controlled ovarian hyperstimulation is achieved with injections of gonadotropin (150IU-300IU/day). Ovulation is induced by hCG injection and retrieved oocytes following in vitro fertilization (IVF/ICSI) are cultured to the blastocyst stage. If this occurs on day 5, then fresh SET/DET (single embryo transfer/double embryo transfer) is performed. Remaining blastocysts are cryopreserved and transferred in subsequent natural cycles/HRT (hormone replacement therapy) that does not involve ovarian stimulation.
    Intervention: Other: in vitro fertilization (IVF/ICSI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
564
January 2014
June 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 38 Years
No
Contact: Maciej W. Feret, MS 212-400-9636 info@ivfclinicaltrial.com
Contact: Henriette Julien, MD 212-400-9626 info@ivfclinicaltrial.com
United States
 
NCT00799929
JZ-09-08, NHFC
Yes
New Hope Fertility Center
New Hope Fertility Center
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • New York Downtown Hospital
Principal Investigator: John J Zhang, MD, MSc, PhD New Hope Fertility Center
New Hope Fertility Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP