Optimal rhCG(Ovidrel®) Dose in Poor Responder During IVF and ICSI Cycles

Seoul National University

Status: Unknown

Conditions: in Vitro Fertilization; Poor Responder

Treatments: Drug: recombinant hCG (Ovidrel®)

Study type: Interventional

Funder types: Other

Identifiers

NCT01406600

hCG dose_oocyte maturity

Details and patient eligibility

About

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.

Full description

Randomized prospective clinical study that compare the two doses of rhCG (250mcg vs. 500mcg).

Enrollment: 70 estimated patients

Sex: Female

Ages: 21 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

rhCG 250mcg

Active Comparator group

Description:

For final oocyte maturation triggering in ART, rhCG 250mcg will be administrated.

Treatment:

Drug: recombinant hCG (Ovidrel®)

rhCG 500mcg

Experimental group

Description:

For final oocyte maturation triggering in ART, rhCG 500mcg will be administrated.

Treatment:

Drug: recombinant hCG (Ovidrel®)