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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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)

NCTNCT00725491 (opens ClinicalTrials.gov in a new tab)Other idP05703Other id38651
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
259 participants (actual)
Sponsor
Organon and Co · Industry
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
May 2007
Primary completion
Dec 2008
Completion
Dec 2008
First posted
30 Jul 2008 (estimated)
Last update posted
3 Feb 2022
Conditions
Controlled Ovarian Stimulation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 3

    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

    May 2007 to Dec 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • ganirelixDrug
  • triptorelinDrug

Arms2

  • Experimental

    1

    ganirelix

  • Active comparator

    2

    triptorelin

Primary outcomes1

Outcomes the sponsor listed as primary.

  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.

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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· At completion of ovarian stimulation; maximally after 18 days of recFSH administration.

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.

GroupValue (international units (IU))Spread
Ganirelix1272.0265.8
Triptorelin1415.6355.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Ganirelix0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).–4 / 11213 / 112
Triptorelin0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG–2 / 12013 / 120

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

8 results

A randomized controlled trial of the GnRH antagonist ganirelix in Chinese normal responders: high efficacy and pregnancy rates.

Qiao et al. 2012Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinologycited by 20

PMID 22429192DOI 10.3109/09513590.2012.665103PUB-22429192

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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