in Vitro Fertilization, Poor Responder
Conditions
Keywords
recombinant hCG, poor responder, oocyte maturity
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).
Interventions
DRUGrecombinant 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| clinical pregnancy rate | After confirming fetal heart beat via transvaginal ultrasound. Usually 2 to 4 weeks after ovum pick-up day. |
Countries
South Korea
Contacts
Primary ContactKyung Eui Park, M.D.
Outcome results
None listed