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

Not Applicable

• Conditions: Poor Responder; in Vitro Fertilization
• Interventions: Drug: recombinant hCG (Ovidrel®)

• Registration Number: NCT01406600
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-07-23
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-08-01
• Study Start: 2011-09
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-11
• Last Update Posted: 2013-04-12
• Primary Completion: 2013-11
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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

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Exclusion Criteria

• patient without informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rhCG 250mcg	recombinant hCG (Ovidrel®)	For final oocyte maturation triggering in ART, rhCG 250mcg will be administrated.
rhCG 500mcg	recombinant hCG (Ovidrel®)	For final oocyte maturation triggering in ART, rhCG 500mcg will be administrated.

Primary Outcome Measures

Name	Time	Method
oocyte maturity	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.	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.

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rate	After confirming fetal heart beat via transvaginal ultrasound. Usually 2 to 4 weeks after ovum pick-up day.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of