IVF Clinical Trial of Two Different Treatment Protocols.
December 22, 2015 updated by: New Hope Fertility Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
564
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10021
- New Hope Fertility Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Primary outcome parameter: Live birth
Time Frame: 4 Years
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4 Years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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4 Years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John J Zhang, MD, MSc, PhD, New Hope Fertility Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (ACTUAL)
May 1, 2014
Study Completion (ACTUAL)
October 1, 2014
Study Registration Dates
First Submitted
November 26, 2008
First Submitted That Met QC Criteria
November 28, 2008
First Posted (ESTIMATE)
December 1, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
December 24, 2015
Last Update Submitted That Met QC Criteria
December 22, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JZ-09-08
- NHFC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.