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)

NCT ID: NCT00725491

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-12-31

Brief 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).

Conditions

Controlled Ovarian Stimulation

Study Design

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

Study Groups

1

ganirelix

Group Type: EXPERIMENTAL

ganirelix

Intervention Type: DRUG

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.

2

triptorelin

Group Type: ACTIVE_COMPARATOR

triptorelin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Orgalutran®; Org 37462; Decapeptyl

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Qiao J, Lu G, Zhang HW, Chen H, Ma C, Olofsson JI, Witjes H, Heijnen E, Mannaerts B. A randomized controlled trial of the GnRH antagonist ganirelix in Chinese normal responders: high efficacy and pregnancy rates. Gynecol Endocrinol. 2012 Oct;28(10):800-4. doi: 10.3109/09513590.2012.665103. Epub 2012 Mar 20.

Reference Type: DERIVED

PMID: 22429192 (View on PubMed)

Other Identifiers

38651

Identifier Type: -

Identifier Source: secondary_id

P05703

Identifier Type: -

Identifier Source: org_study_id