A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)

Controlled Ovarian Stimulation Clinical Trial

Official title:

A Phase III, Multi-center, Open-label, Randomized Study to Assess the Efficacy and Safety of Org 37462 Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for IVF or ICSI, Using a Long Protocol of Triptorelin as a Reference Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725491
• Other study ID #: P05703
• Secondary ID: 38651
• Status: Completed
• Phase: Phase 3
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• females of infertile couples for whom COS and IVF or ICSI is indicated
• body mass index between 18 and 29 kg/m2
• willing and able to give written informed consent.

Exclusion Criteria:

• More than three previous COS cycles for assisted reproduction since last established ongoing pregnancy (if applicable)
• History of no or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment
• Less than 2 ovaries or any other ovarian abnormality including endometrioma
• Presence of unilateral or bilateral hydrosalpinx
• Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of at least one ovary
• History of or current polycystic ovary syndrome (PCOS)
• History of/or current endocrine abnormality
• Any clinically relevant hormone value outside the reference range during the early follicular phase
• Any clinically significant abnormal laboratory value
• Hypertension or currently treated hypertension
• Recent history of current epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary disease
• Alcohol or drug abuse, or history thereof
• Current serious allergic symptoms
• Abnormal cervical smear
• Known hypersensitivity to gonadotropin releasing hormone (GnRH) or its analogs;
• Contra-indications for the use of gonadotropins
• Use of hormonal preparations within 1 month prior to the date of signing consent;
• Administration of any investigational product within 3 months prior to screening.

Related Conditions & MeSH terms

• Controlled Ovarian Stimulation

Intervention

Drug:
• ganirelix
On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration.
• triptorelin
a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Treatment with recFSH will start 14 days later if treatment with triptorelin has resulted in downregulation, i.e. serum E2 <= 50 pg/ml (<= 200pmol/l). In case the hypogonadotropic state is not reached after 14 days of pretreatment, the dose of triptorelin will be increased to 0.1 mg. If downregulation is not reached within 28 days of pre-treatment with triptorelin, the subject will be discontinued from further hormonal treatment. The daily dose of triptorelin is sustained up to and including the day of hCG.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.	The hCG criterion is met the first day that 3 follicles >= 17 mm are observed.	At completion of ovarian stimulation; maximally after 18 days of recFSH administration.