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)

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01081756
First received: March 4, 2010
Last updated: July 30, 2014
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: r-hCG
Drug: Urinary-hCG
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Number of oocyte retrieved [ Time Frame: 36 hrs after hCG administration ] [ Designated as safety issue: Yes ]

Enrollment: 218
Study Start Date: December 2003
Study Completion Date: September 2004
Arms Assigned Interventions
Experimental: Subjects treated with r-hCG
Subjects treated with r-hCG
Drug: r-hCG
r-hCG (250 mcg) injection subcutaneously (s.c.) or intramuscularly (i.m.)
Other Name: Ovitrelle or Ovidrel
Active Comparator: Subjects treated with urinary hCG
Subjects treated with urinary hCG
Drug: Urinary-hCG
Urinary hCG (10,000 IU) injection s.c. or i.m.
Other Name: Profasi

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081756

Locations
China
Peking University 3rd Hopistal
Beijing, China, 100191
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Huafei Li Serono Singapore
  More Information

No publications provided

Responsible Party: Medical Director, Serono Singapore, an affiliate of Merck KGaA, Darmstadt, Germany.
ClinicalTrials.gov Identifier: NCT01081756     History of Changes
Other Study ID Numbers: IMP-25346
Study First Received: March 4, 2010
Last Updated: July 30, 2014
Health Authority: China: Ministry of Health

Keywords provided by Merck KGaA:
Reproductive technology; Assisted
recombinant human chorionic hormone (r-hCG)

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Chorionic Gonadotropin
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014