RCT of Low-dose Clomiphene vs. High Dose Gonadotropin Protocol for IVF Poor Responders
NCT ID: NCT01577199
Last Updated: 2016-12-16
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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WITHDRAWN
PHASE4
INTERVENTIONAL
2012-04-30
2012-12-31
Brief Summary
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Detailed Description
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Patients meeting the criteria for poor ovarian response will be consented and randomized to either a stimulation protocol involving pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge (the hormone released by the brain to cause ovulation to occur, which is detectable in urine) followed by oral clomiphene citrate 100mg on days 2-6 of the menstrual cycle and 225 international units of gonadotropins starting on day 5, or to the control group involving the same pretreatment with 0.1mg luteal estradiol patches starting 10 days after the LH surge, with high dose gonadotropins (600IU) alone, starting on day 2 of the cycle. After randomization, patients will undergo routine IVF procedures, monitoring, blood draws, cancellation criteria, oocyte retrieval, and embryo transfer as non-study participants.
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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High dose gonadotropins
High dose gonadotropins protocol compared to Low-dose Clomiphene
High dose gonadotropins
Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed high dose gonadotropins (eg. Follistim. Menopur) 600IU starting on day 2 of the cycle
Low-dose Clomiphene
clomid-based, low dose gonadotropin protocol compared to High dose gonadotropins
Low-dose Clomiphene
Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed by clomiphene citrate 100mgon days 2-6 of the menstrual cycle with 225 international units of gonadotropins (eg Follistim , Menopur) starting on day 5
Interventions
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Low-dose Clomiphene
Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed by clomiphene citrate 100mgon days 2-6 of the menstrual cycle with 225 international units of gonadotropins (eg Follistim , Menopur) starting on day 5
High dose gonadotropins
Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed high dose gonadotropins (eg. Follistim. Menopur) 600IU starting on day 2 of the cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* AFC \<7 (see definition above) and AMH (see definition above) \<0.5 and/or prior poor IVF response
Exclusion Criteria
* PGD (preimplantation genetic diagnosis, in which embryos are biopsied to rule out chromosomal abnormalities)
* Age \>42
* Fragile X carriers (a condition associated with premature ovarian aging)
* TESE (Testicular sperm extraction)
* Asherman's syndrome (uterine scarring which can affect implantation and pregnancy)
* Untreated hydrosalpinx (accumulated fluid in the fallopian tube which may be toxic to embryos)
* \>6 prior attempted cycles
18 Years
42 Years
FEMALE
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Owen Davis, MD
Role: PRINCIPAL_INVESTIGATOR
WCMC
Countries
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Related Links
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Center for Reproductive Medicine
Other Identifiers
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1112012095
Identifier Type: -
Identifier Source: org_study_id