IVF Clinical Trial of Two Different Treatment Protocols.

Infertility Clinical Trial

Official title:

Efficiency and Patient Satisfaction of Two Different IVF Protocols.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799929
• Other study ID #: JZ-09-08
• Secondary ID: NHFC
• Status: Completed
• Phase: N/A
• First received: November 26, 2008
• Last updated: December 22, 2015
• Start date: December 2008
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: New Hope Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. completion date: October 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• in vitro fertilization (IVF/ICSI)

Locations

Country	Name	City	State
United States	New Hope Fertility Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New Hope Fertility Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome parameter: Live birth		4 Years	Yes
Secondary	Secondary outcome parameters: Biochemical pregnancy, Clinical pregnancy, Ongoing pregnancy, Multiple pregnancy rate, Miscarriage rate, Fertilization rate, Number of oocytes, Number of embryos		4 Years	Yes

External Links

•   To apply for this study please visit www.ivfclinicaltrial.com and go to "Pre-Screening Quiz" (Located on the bottom left side of the website's home page).