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

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

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

Conditions
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in Vitro Fertilization, Poor Responder

Intervention / Treatment
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* Drug: recombinant hCG (Ovidrel®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rhCG 250mcg<br>For final oocyte maturation triggering in ART, rhCG 250mcg will be administrated. | Drug: recombinant hCG (Ovidrel®)<br>* 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.<br>|
| Experimental: rhCG 500mcg<br>For final oocyte maturation triggering in ART, rhCG 500mcg will be administrated. | Drug: recombinant hCG (Ovidrel®)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | After confirming fetal heart beat via transvaginal ultrasound. Usually 2 to 4 weeks after ovum pick-up day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recombinant hCG, poor responder, oocyte maturity