IVF Clinical Trial of Two Different Treatment Protocols.
NCT ID: NCT00799929
Last Updated: 2015-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
564 participants
INTERVENTIONAL
2008-12-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
in vitro fertilization (IVF/ICSI)
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.
in vitro fertilization (IVF/ICSI)
Interventions
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in vitro fertilization (IVF/ICSI)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
38 Years
FEMALE
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
New Hope Fertility Center
OTHER
Responsible Party
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Principal Investigators
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John J Zhang, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
New Hope Fertility Center
Locations
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New Hope Fertility Center
New York, New York, United States
Countries
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References
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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.
Other Identifiers
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NHFC
Identifier Type: -
Identifier Source: secondary_id
JZ-09-08
Identifier Type: -
Identifier Source: org_study_id