A Phase 4 interventional study of Low-dose Clomiphene and High dose gonadotropins in Infertility, sponsored by Weill Medical College of Cornell University. Withdrawn. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2016-12-16.
Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Treatment
The purpose of this study is compare two commonly-used medication protocols ( low-dose clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF. This research is being done because we do not know if these two medication protocols are equally likely to help a woman become pregnant.
The objective of this protocol is to prospectively evaluate whether a clomid-based, low dose gonadotropin protocol (225 IU) would be non-inferior in terms of mature oocyte yield (eggs that are ready to be fertilized) as compared to a high-dose protocol.
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.
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Exclusion Criteria:
High dose gonadotropins protocol compared to Low-dose Clomiphene
Drug: High dose gonadotropins
clomid-based, low dose gonadotropin protocol compared to High dose gonadotropins
Drug: 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
Also known as: clomiphene citrate with low 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
Also known as: Gonal F or Follistim
The number of mature oocytes retrieved
To evaluate the number of mature oocytes retrieved in two different IVF protocols for poor responders
Time frame: 1 year
The number of embryos transferred
To evaluate the number of embryos transferred
Time frame: 1year
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University