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 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081756
• Other study ID #: IMP-25346
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2010
• Last updated: July 30, 2014
• Start date: December 2003
• Est. completion date: September 2004

Study information

• Verified date: March 2010
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• r-hCG
r-hCG (250 mcg) injection subcutaneously (s.c.) or intramuscularly (i.m.)
• Urinary-hCG
Urinary hCG (10,000 IU) injection s.c. or i.m.

Locations

Country	Name	City	State
China	Peking University 3rd Hopistal	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocyte retrieved		36 hrs after hCG administration	Yes