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)

NCT ID: NCT01081756

Last Updated: 2014-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2004-09-30

Brief Summary

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.

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects treated with r-hCG

Subjects treated with r-hCG

Group Type: EXPERIMENTAL

r-hCG

Intervention Type: DRUG

r-hCG (250 mcg) injection subcutaneously (s.c.) or intramuscularly (i.m.)

Subjects treated with urinary hCG

Subjects treated with urinary hCG

Group Type: ACTIVE_COMPARATOR

Urinary-hCG

Intervention Type: DRUG

Urinary hCG (10,000 IU) injection s.c. or i.m.

Interventions

r-hCG

r-hCG (250 mcg) injection subcutaneously (s.c.) or intramuscularly (i.m.)

Intervention Type: DRUG

Urinary-hCG

Urinary hCG (10,000 IU) injection s.c. or i.m.

Intervention Type: DRUG

Other Intervention Names

Ovitrelle or Ovidrel; Profasi

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Serono Singapore, an affiliate of Merck KGaA, Darmstadt, Germany.

Principal Investigators

Huafei Li

Role: STUDY_DIRECTOR

Serono Singapore

Locations

Peking University 3rd Hopistal

Beijing, , China

Countries

China

Other Identifiers

IMP-25346

Identifier Type: -

Identifier Source: org_study_id