An interventional study of recombinant hCG (Ovidrel®) in in Vitro Fertilization and Poor Responder, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 21 Years to 44 Years. Per ClinicalTrials.gov, last updated 2013-04-12.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
Choriogonadotropin alfa (Ovidrel®) is a recombinant hCG (rhCG) preparation derived from genetically engineered Chinese hamster ovary cells, which is widely used for final oocyte maturation triggering in assisted reproductive technology (ART).Recombinant hCG has been investigated about its safety and efficacy comparing with urinary hCG, but still the optimal dose of rhCG is questionable. From former studies, there only have been proven that high dose of hCG can make ovarian hyperstimulation syndrome (OHSS) in usual condition. On the other hand, we hypothesize that high dose of hCG may improve oocyte maturity in poor responders who cannot easily provoke OHSS. Hence, this study will assess the comparative efficacy and safety of 250mcg and 500mcg of rhCG in ART treatment cycle.
Randomized prospective clinical study that compare the two doses of rhCG (250mcg vs. 500mcg).
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For final oocyte maturation triggering in ART, rhCG 250mcg will be administrated.
Drug: recombinant hCG (Ovidrel®)
For final oocyte maturation triggering in ART, rhCG 500mcg will be administrated.
Drug: recombinant hCG (Ovidrel®)
Recombinant hCG (Ovidrel®)will be administrated for final oocyte maturation triggering in poor responders with different two doses (250mcg vs. 500mcg). Usually rhCG is administrated after 24\~48 hours from optimal ovarian stimulation status.
oocyte maturity
After administration of different doses of rhCG, oocyte maturity will be assessed on ovum pick up day. Oocytes will be classified into GV, MI, and MII.
Time frame: Up to the ovum pick up day. At the point of ovum pick-up, we can count how many mature or immature oocytes were retrived. Therefore, in one hour after ovum pick-up, outcome measurement will be possible.
clinical pregnancy rate
Time frame: After confirming fetal heart beat via transvaginal ultrasound. Usually 2 to 4 weeks after ovum pick-up day.
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital