Back to resultsIVF Clinical Trial of Two Different Treatment Protocols.
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
in vitro fertilization (IVF/ICSI)
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring IVF Research Study, Infertility Sudy, in vitro fertilization, Mini IVF, Conventional IVF
Eligibility 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
Sites / Locations
- New Hope Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ARM A - Mini IVF
Arm B - Conventional IVF
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Primary outcome parameter: Live birth
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
Full Information
NCT ID
NCT00799929
First Posted
November 26, 2008
Last Updated
December 22, 2015
Sponsor
New Hope Fertility Center
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT00799929
Brief Title
IVF Clinical Trial of Two Different Treatment Protocols.
Official Title
Efficiency and Patient Satisfaction of Two Different IVF Protocols.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Hope Fertility Center
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF Research Study, Infertility Sudy, in vitro fertilization, Mini IVF, Conventional IVF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
564 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARM A - Mini IVF
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm B - Conventional IVF
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
in vitro fertilization (IVF/ICSI)
Primary Outcome Measure Information:
Title
Primary outcome parameter: Live birth
Time Frame
4 Years
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Zhang, MD, MSc, PhD
Organizational Affiliation
New Hope Fertility Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Hope Fertility Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28620528
Citation
Zhang JJ, Yang M, Merhi Z. Efficiency of metaphase II oocytes following minimal/mild ovarian stimulation in vitro fertilization. Fertil Res Pract. 2016 Sep 1;2:2. doi: 10.1186/s40738-016-0025-6. eCollection 2016.
Results Reference
derived
Links:
URL
http://www.ivfclinicaltrial.com/
Description
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).
Learn more about this trial
IVF Clinical Trial of Two Different Treatment Protocols.
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