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)

An Open, Randomized, Comparative 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)

This was an open, randomized, comparative study using rhCG (Ovidrel) in the induction of final follicle maturation and early luteinization in Chinese female subjects undergoing IVF or ET.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: r-hCG; Drug: Urinary-hCG

Detailed Description

This was an open, randomized, comparative multicentric, phase III study to evaluate the safety and efficacy of rhCG in comparison with urinary hCG in the induction of final follicle maturation and early luteinization in 200 Chinese female subjects undergoing superovulation. The study was organized on an outpatient basis in subjects undergoing assisted reproductive technologies (ART). All subjects underwent pituitary down- regulation per each center's normal practice prior to and during stimulation of multiple follicular development. The subjects were randomized into 2 groups. One group received rhCG 250mcg and the other group received urinary hCG (Profasi®) 10,000IU. Each subject in both groups received a single injection of hCG when the follicular development was judged to be adequate. Oocytes were retrieved 36-38 hours after the hCG injection and fertilized in vitro. Not more than 3 embryos or 2 blastocysts were to be replaced. Progesterone was administered daily according to center's normal practice, starting after the oocyte pick up and continuing until a negative pregnancy test or for the first 3 weeks of pregnancy if the subject was pregnant. The subject was followed up and the treatment outcome (negative pregnancy test or pregnancy) was recorded.

A phase I sub-study to evaluate the pharmacokinetics of single subcutaneous (s.c.) administrations of rhCG was conducted on 24 healthy Chinese female subjects in China. The subjects were randomized into 3 groups. Each group received a single dose of 250mcg or 500mcg or 750 mcg of rhCG. Blood samples were collected at predetermined intervals after the injection. Human chorionic gonadotropin serum levels were measured with the Serono MAIAclone and the in vitro bioassay MA-10. Safety was assessed by the incidence and severity of adverse events (AEs), including multiple pregnancy and ovarian hyperstimulation syndrome (OHSS) and significant changes in laboratory values.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • Peking University 3rd Hopistal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Exclusion Criteria:

• With a poor response to gonadotrophin stimulation, such as ≤3 oocytes collected in any previous IVF cycle
• Any medical condition may interfere with the absorption, distribution, metabolism or excretion of the drug.
• Had previous severe ovarian hyperstimulation syndrome(OHSS)
• A body mass index (BMI) >25 kg/m2
• Any contraindication to being pregnant and/or carrying a pregnancy to term
• Extra-uterine pregnancy within the last 3 months
• A clinically significant systemic disease
• Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus
• Abnormal gynaecological bleeding of undetermined origin
• Known allergy or hypersensitivity to human gonadotrophin preparations
• Simultaneous participation in another clinical trial

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects treated with r-hCG	Drug: r-hCG; r-hCG (250 mcg) injection subcutaneously (s.c.) or intramuscularly (i.m.); Other Names: Ovitrelle or Ovidrel
Active Comparator: Subjects treated with urinary hCG	Drug: Urinary-hCG; Urinary hCG (10,000 IU) injection s.c. or i.m.; Other Names: Profasi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of oocyte retrieved	36 hrs after hCG administration

Collaborators and Investigators

• Sponsor: Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Huafei Li, Serono Singapore

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: March 4, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Estimate): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 30, 2014
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Reproductive technology; Assisted; recombinant human chorionic hormone (r-hCG)
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Reproductive Control Agents; Chorionic Gonadotropin
• Other Study ID Numbers: IMP-25346