Efficiency and Patient Satisfaction of Two Different IVF Protocols - Full Text View

Sponsored by:	New Hope Fertility Center
Information provided by:	New Hope Fertility Center
ClinicalTrials.gov Identifier:	NCT00799929

Purpose

The trial is designed to compare hyper-stimulation and minimal-stimulation IVF protocols, in terms of multiple-pregnancy rate and treatment cost. The study will also seek to find which of the two methods is more patient-friendly: comparing the psychological impact of these two IVF treatments, as well as the side effects of drugs required by the respective protocols.

Condition	Intervention
Infertility	Other: Subjects undergoing the minimal-stimulation IVF protocol. Other: Subjects undergoing the hyper-stimulation IVF protocol.

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Efficiency and Patient Satisfaction of Two Different IVF Protocols.

Resource links provided by NLM:

MedlinePlus related topics: Infertility

U.S. FDA Resources

Further study details as provided by New Hope Fertility Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	564
Study Start Date:	December 2008
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Subjects undergoing the minimal-stimulation IVF protocol.	Other: Subjects undergoing the minimal-stimulation IVF protocol. Subjects undergoing the minimal-stimulation IVF protocol.
B: Active Comparator Subjects undergoing the hyper-stimulation IVF protocol.	Other: Subjects undergoing the hyper-stimulation IVF protocol. Subjects undergoing the hyper-stimulation 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 or ICSI
First IVF/ICSI attempt
Couples or female, with female between the ages of 18 and 38 years
If couple, partner 18 years of age or older
Both partners HIV free.
Must be able to understand that they may NOT become pregnant..
Female must be able to understand that she can not use the following medications during undergoing IVF:

Advil, Alleve, Anaprox, Bactrim, Botox, Celebrex, Claritin D, Flax Seed Oil, Flexeril, Methotrexate, Motrin, Norethindrone, Phenobarbital, Procrin, Septra DS, Sudafed, Sulfa Methorzple Trimethoprim, Tylenol Cold & Sinus, Vioxx

Exclusion Criteria:

Not willing or able to sign the consent form.
Either partner has symptoms of a sexually transmitted infection (including: Chlamydia, Gonorrhea, Syphilis) and has not been treated.
Female with active Varicella or/and Rubella infection.
Either partner with Hepatitis A, B or C and has not been treated.
Positive Genetic test results for: Fragile X (only if both partners are carriers), Cystic Fibrosis, Ashkenazi Panel (for Jewish Subjects) Hemoglobin Electrophoresis (for Asian, Latinos and African Americans)
Abnormal Pap Smear.
Abnormal Colposcopy.
Female with Polycystic Ovary Syndrome without regular period (PCOS)with irregular menses.
Female with diabetes, heart disease or/and has had heart attack or stroke.

Contacts and Locations

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

Contacts

Contact: Maciej W. Feret, MS	212-400-9636	maciej.feret@newhopefertility.com
Contact: Mari Santocildes, BS	212-400-9634	mari@newhopefertility.com

Locations

United States, New York
New Hope Fertility Center	Recruiting
New York, New York, United States, 10021
Contact: Maciej Feret, MS 212-400-9636 maciej.feret@newhopefertility.com
Principal Investigator: John J. Zhang, MD, MSc, PhD
Sub-Investigator: Fulco van der Veen, MD, PhD
Sub-Investigator: Sjoerd Repping, PhD
Sub-Investigator: Madelon van Wely, PhD
Sub-Investigator: Lyndon Chang, MD

Sponsors and Collaborators

New Hope Fertility Center

Investigators

Principal Investigator:

John J Zhang, MD, MSc, PhD

New Hope Fertility Center

More Information

No publications provided

Responsible Party:	New Hope Fertility Center ( Principal Investigator )
Study ID Numbers:	JZ-09-08, NHFC
Study First Received:	November 26, 2008
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00799929 History of Changes
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

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Genital Diseases, Male

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on September 10, 2009