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

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seok Hyun Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01406600
First received: July 23, 2011
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
in Vitro Fertilization
Poor Responder
Drug: recombinant hCG (Ovidrel®)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimal rhCG(Ovidrel®) Dose for Final Oocyte Maturation Triggering in Poor Responder During IVF and ICSI Cycles

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • oocyte maturity [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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:
  • clinical pregnancy rate [ Time Frame: After confirming fetal heart beat via transvaginal ultrasound. Usually 2 to 4 weeks after ovum pick-up day. ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rhCG 250mcg
For final oocyte maturation triggering in ART, rhCG 250mcg will be administrated.
Drug: 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.
Experimental: rhCG 500mcg
For final oocyte maturation triggering in ART, rhCG 500mcg will be administrated.
Drug: 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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406600

Contacts
Contact: Kyung Eui Park, M.D. +82-2-2072-3529 kepark.md@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Kyung Eui Park, M.D.    +82-2-2072-3529    kepark.md@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seok Hyun Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01406600     History of Changes
Other Study ID Numbers: hCG dose_oocyte maturity
Study First Received: July 23, 2011
Last Updated: April 11, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
recombinant hCG
poor responder
oocyte maturity

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014