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)

NCT00725491 | Completed Phase 3 Results

• 2 other identifiers: P0570338651
• Study Type: interventional
• Target: 259
• Locations: 0 countries
• Sites: N/A

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

Keywords

Reproductive; techniques; assisted

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

1

EXPERIMENTAL

ganirelix

Drug: ganirelix

2

ACTIVE COMPARATOR

triptorelin

Drug: triptorelin

Interventions

ganirelix 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.

Also known as: Orgalutran®, Org 37462

1

triptorelin 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.

Also known as: Decapeptyl

2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 22429192 DERIVED

MeSH Terms

Conditions

Helping Behavior

Interventions

ganirelix; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 3, 2022
• Results First Posted: January 22, 2010

Record last verified: 2022-02