Current partner codePEPTIDESDE
NCT00725491·Phase 3·INTERVENTIONAL

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)

Status

Completed

Phase

Phase 3

Enrollment

259

Locations

0

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

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.

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.

Timeline

From registration to results.

  1. First posted

    Jul 30, 2008

  2. Study start

    May 2007

  3. Primary completion

    Dec 2008

  4. Study completion

    Dec 2008

  5. Results posted

    Jan 22, 2010

  6. Registry updated

    Feb 3, 2022

Outcomes

What the study measures.

Primary outcomes

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.

Time frame · At completion of ovarian stimulation; maximally after 18 days of recFSH administration.

The hCG criterion is met the first day that 3 follicles \>= 17 mm are observed.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
35 Years
Sex
FEMALE
Healthy volunteers
No

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.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Related trials

More studies on Ganirelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.