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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014