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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

Page last updated: August 23, 2015

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