Optimal rhCG(Ovidrel®) Dose in Poor Responder During IVF and ICSI Cycles
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: in Vitro Fertilization; Poor Responder
Intervention: recombinant hCG (Ovidrel®) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Seoul National University Hospital Overall contact: Kyung Eui Park, M.D., Phone: +82-2-2072-3529, Email: kepark.md@gmail.com
Summary
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.
Clinical Details
Official title: Optimal rhCG(Ovidrel®) Dose for Final Oocyte Maturation Triggering in Poor Responder During IVF and ICSI Cycles
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: oocyte maturity
Secondary outcome: clinical pregnancy rate
Detailed description:
Randomized prospective clinical study that compare the two doses of rhCG (250mcg vs.
500mcg).
Eligibility
Minimum age: 21 Years.
Maximum age: 44 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- poor response in prior IVF cycle (≤ 4 oocyte retrieved)
- women's age ≥ 40 years
- FSH ≥ 10mIU/mL or AMH ≤ 1. 1ng/mL
- Antral follicle count <6
Exclusion Criteria:
- patient without informed consent
Locations and Contacts
Kyung Eui Park, M.D., Phone: +82-2-2072-3529, Email: kepark.md@gmail.com
Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting Kyung Eui Park, M.D., Phone: +82-2-2072-3529, Email: kepark.md@gmail.com
Additional Information
Starting date: September 2011
Last updated: April 11, 2013
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