Optimal rhCG(Ovidrel®) Dose in Poor Responder During IVF and ICSI Cycles
Optimal rhCG(Ovidrel®) Dose for Final Oocyte Maturation Triggering in Poor Responder During IVF and ICSI Cycles
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2011
CompletedFirst Posted
Study publicly available on registry
August 1, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 12, 2013
April 1, 2013
2.2 years
July 23, 2011
April 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
oocyte maturity
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.
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.
Secondary Outcomes (1)
clinical pregnancy rate
After confirming fetal heart beat via transvaginal ultrasound. Usually 2 to 4 weeks after ovum pick-up day.
Study Arms (2)
rhCG 250mcg
ACTIVE COMPARATORFor final oocyte maturation triggering in ART, rhCG 250mcg will be administrated.
rhCG 500mcg
EXPERIMENTALFor final oocyte maturation triggering in ART, rhCG 500mcg will be administrated.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patient without informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Seok Hyun Kim
Study Record Dates
First Submitted
July 23, 2011
First Posted
August 1, 2011
Study Start
September 1, 2011
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
April 12, 2013
Record last verified: 2013-04