IVF Clinical Trial of Two Different Treatment Protocols.

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
New Hope Fertility Center
ClinicalTrials.gov Identifier:
NCT00799929
First received: November 26, 2008
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Infertility
Other: in vitro fertilization (IVF/ICSI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficiency and Patient Satisfaction of Two Different IVF Protocols.

Resource links provided by NLM:


Further study details as provided by New Hope Fertility Center:

Primary Outcome Measures:
  • Primary outcome parameter: Live birth [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 564
Study Start Date: December 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other: in vitro fertilization (IVF/ICSI)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799929

Locations
United States, New York
New Hope Fertility Center
New York, New York, United States, 10021
Sponsors and Collaborators
New Hope Fertility Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: John J Zhang, MD, MSc, PhD New Hope Fertility Center
  More Information

Additional Information:
No publications provided

Responsible Party: New Hope Fertility Center
ClinicalTrials.gov Identifier: NCT00799929     History of Changes
Other Study ID Numbers: JZ-09-08, NHFC
Study First Received: November 26, 2008
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New Hope Fertility Center:
IVF Research Study
Infertility Sudy
in vitro fertilization
Mini IVF
Conventional IVF

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014