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

in Vitro Fertilization Clinical Trial

Official title:

Optimal rhCG(Ovidrel®) Dose for Final Oocyte Maturation Triggering in Poor Responder During IVF and ICSI Cycles

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01406600
• Other study ID #: hCG dose_oocyte maturity
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2011
• Last updated: April 11, 2013
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2013
• Source: Seoul National University Hospital
• Contact: Kyung Eui Park, M.D.
• Phone: +82-2-2072-3529
• Email: kepark.md[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• in Vitro Fertilization
• Poor Responder

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	clinical pregnancy rate		After confirming fetal heart beat via transvaginal ultrasound. Usually 2 to 4 weeks after ovum pick-up day.	No