AzTrials
AzTrials

Controlled Ovarian StimulationPhase 3NCT00725491

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)

A Phase 3 study testing ganirelix and triptorelin in people with Controlled Ovarian Stimulation, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Controlled Ovarian Stimulation
What is being tested?
ganirelix and triptorelin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
259 participants
Where
No sites listed yet
Study dates
May 2007to Dec 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 18Show fewer
  • 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.

About this study

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.

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).

Being tested
ganirelix, triptorelin
Keywords
Reproductive, techniques, assisted
Medical subject headings
Helping Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ganirelixDrug

    Also called Orgalutran®, Org 37462

    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.

  • triptorelinDrug

    Also called Decapeptyl

    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.

Study groups in NCT00725491
Study groupRoleWhat they receive
1Experimentalganirelix
Receives: Drug: ganirelix
2Active comparatortriptorelin
Receives: Drug: triptorelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At completion of ovarian stimulation; maximally after 18 days of recFSH administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00725491
Sponsor's protocol ID
P05703
Other IDs
38651
Status last verified
Feb 2022
First submitted
28 Jul 2008
Last updated
3 Feb 2022
Data monitoring committee
No

Publications

  • 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.

    PubMed 22429192

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ganirelix and triptorelin in people with Controlled Ovarian Stimulation, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: At completion of ovarian stimulation; maximally after 18 days of recFSH administration.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00725491, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in