Clinical trial NCT00725491: 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)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Controlled Ovarian Stimulation
Keywords: Reproductive
techniques
assisted
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 259
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: 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.
timeFrame: At completion of ovarian stimulation; maximally after 18 days of recFSH administration.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.