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r-hCG

Phase 3

Infertility | Small molecule | Other |Merck KGaA|Last Updated: Jul 31, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment218

FDA Designations

No designations recorded

Clinical trial landscape

r-hCG · 1 trial · 1 indication

Phase 3 1
NCT01081756A Study Using Recombinant Human Chorionic Gonadotrophin (rhCG, Ovidrel®) in the Induction of Final Follicle Maturation and Early Luteinization in Chinese Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)Infertility
COMPLETED218 Analytics
PHASE3COMPLETED
A Study Using Recombinant Human Chorionic Gonadotrophin (rhCG, Ovidrel®) in the Induction of Final Follicle Maturation and Early Luteinization in Chinese Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)
Infertility
NCT01081756218
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Study Endpoints

Primary Endpoints

Number of oocyte retrieved
36 hrs after hCG administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects treated with r-hCGEXPERIMENTALSubjects treated with r-hCG
Subjects treated with urinary hCGACTIVE_COMPARATORSubjects treated with urinary hCG

Interventions

NameTypeDescription
r-hCGDRUGr-hCG (250 mcg) injection subcutaneously (s.c.) or intramuscularly (i.m.)
Urinary-hCGDRUGUrinary hCG (10,000 IU) injection s.c. or i.m.
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Eligibility Criteria

SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Infertility regular ovulatory menstrual cycles; * Early luteal phase serum levels: * FSH≤ 10IU/l * LH≤ 10IU/l * PRL≤ 30ng/ml * T≤ 50pg/ml * Haematology, blood chemistry, urinalysis normal * Both ovaries present * \< 3 previous ART cycles, no ART cycles for 2 menstrual cycles ...

Countries:China
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Frequently asked questions about r-hCG

What is r-hCG used for?

r-hCG, also known as recombinant human chorionic gonadotrophin, is used for infertility. Specifically, it is studied for the induction of final follicle maturation and early luteinization in Chinese women undergoing in vitro fertilization and embryo transfer (IVF/ET).

What does r-hCG target?

r-hCG targets the luteinizing hormone/choriogonadotropin receptor. By mimicking the action of luteinizing hormone, it triggers final follicle maturation and early luteinization, which are critical steps in the IVF process.

Who makes r-hCG?

r-hCG is developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is being investigated for use in infertility treatment.

What phase is r-hCG in?

r-hCG is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed.

What clinical trials is r-hCG in?

r-hCG has one completed Phase 3 clinical trial, identified as NCT01081756. This study enrolled 218 female participants in China and evaluated the drug for inducing final follicle maturation and early luteinization in women undergoing IVF/ET.

Is r-hCG the same as Ovidrel?

Yes, r-hCG is also known as Ovidrel. In the clinical trial, the drug is referred to as recombinant human chorionic gonadotrophin (rhCG, Ovidrel®), indicating that Ovidrel is a brand name for r-hCG.