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

NCT ID: NCT01406600

Last Updated: 2013-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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in Vitro Fertilization Poor Responder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rhCG 250mcg

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

Group Type ACTIVE_COMPARATOR

recombinant hCG (Ovidrel®)

Intervention Type DRUG

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.

rhCG 500mcg

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

Group Type EXPERIMENTAL

recombinant hCG (Ovidrel®)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seok Hyun Kim

Seok Hyun Kim

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kyung Eui Park, M.D.

Role: CONTACT

+82-2-2072-3529

Facility Contacts

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Kyung Eui Park, M.D.

Role: primary

+82-2-2072-3529

Other Identifiers

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hCG dose_oocyte maturity

Identifier Type: -

Identifier Source: org_study_id

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