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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01406600

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
in Vitro Fertilization Poor Responder	Drug: recombinant hCG (Ovidrel®)	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Nov 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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®)

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seok Hyun Kim, Seok Hyun Kim, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01406600

Other Study ID Numbers:

hCG dose_oocyte maturity

First Posted:

Aug 1, 2011

Last Update Posted:

Apr 12, 2013

Last Verified:

Apr 1, 2013

Keywords provided by Seok Hyun Kim, Seok Hyun Kim, Seoul National University Hospital

recombinant hCG

poor responder

oocyte maturity

Additional relevant MeSH terms:

Chorionic Gonadotropin

Study Results

No Results Posted as of Apr 12, 2013