NCT00988260

Brief Summary

The purpose of this study is to find the optimal dose of Org 37462 for Japanese females undergoing controlled ovarian stimulation for in vitro fertilization intracytoplasmic sperm injection (IVF-ICSI).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2004

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

October 1, 2009

Last Update Submit

August 13, 2024

Conditions

Controlled Ovarian Stimulation

Outcome Measures

Primary Outcomes (2)

  • Incidence of Luteinizing Hormone (LH) rise

    During treatment (1-14 days)

  • Intrauterine vital pregnancy rate

    5-6 weeks after embryo transfer (ET)

Study Arms (3)

Ganirelix 0.125 mg

EXPERIMENTAL
Drug: Ganirelix

Ganirelix 0.25 mg

EXPERIMENTAL
Drug: Ganirelix

Ganirelix 0.5 mg

EXPERIMENTAL
Drug: Ganirelix

Interventions

GanirelixDRUG

Ganirelix 0.125 mg subcutaneous daily (SC OD) for up to 14 days

Also known as: Org 37462, SCH 900761, Orgalutran, Ganirelix Acetate, Ganirest
Ganirelix 0.125 mg

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Japanese females of infertile married couples with an indication for COH and IVF with or without ICSI.
  • At least 20 but not older than 39 years of age at the time of screening.
  • A body mass index (BMI) between 18 and 29.
  • Normal menstrual cycle with a range of 24-35 days and an intra-individual variation of plus or minus 3 days (but never outside the 24-35 days range).
  • Infertile couple that is willing to give written informed consent.
  • is determined in view of the planned therapeutic indication.
  • is determined based on ethical considerations for the subjects (not younger than 20) and also in view of the planned therapeutic indication (not older than 39)
  • is determined to avoid bias on the effects of Org 37462 by emaciation and obesity.
  • is determined to avoid the influences of endogenous hormones considering the purpose of this trial to select the minimal effective dose of Org 37462.
  • is determined from the ethical consideration of the subjects.

You may not qualify if:

  • History of/or current endocrine abnormality such as polycystic ovary syndrome (PCOS) or polycystic ovaries according to USS, (treated) hyperprolactinemia or evidence of ovarian dysfunction.
  • History of non- or low- ovarian response to FSH/hMG treatment.
  • Abnormal cervical smear according to the Papanicolaou (\>= class III) or Bethesda (\>= CIN 1) scale.
  • History of/or current Type I hypersensitivity (urticaria, eczema, hay fever, asthma), meaning that the subject is using prescribed medication on a regular basis or that the subjects history is prohibitive for Org 37462 treatment according to the clinical opinion of the sub-investigator.
  • Any hormone value outside the reference range during the early follicular phase as measured by the central laboratory (Japan) \[FSH, LH, E2, P, androstenedione (AD), dehydroepiandrosterone sulphate (DHEAS), testosterone (T), thyroid stimulating hormone (TSH) and prolactin\].
  • Any clinically significant abnormal laboratory value of the central laboratory (Japan) (routine hematology, blood biochemistry).
  • Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of both ovaries, thus excluding subjects with only one ovary.
  • Contra-indications for the use of gonadotropins i.e.,
  • tumors of ovary, breast, uterus, pituitary or hypothalamus.
  • pregnancy or lactation.
  • undiagnosed vaginal bleeding.
  • hypersensitivity to any of the substances in recFSH (FSH, sucrose, sodium citrate, polysorbate 20 and sodium chloride, L-methionine).
  • ovarian cysts or enlarged ovaries not related to PCOS.
  • malformation of the sexual organs incompatible with pregnancy.
  • fibroid tumors of the uterus incompatible with pregnancy.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

ganirelix

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

February 3, 2003

Primary Completion

April 12, 2004

Study Completion

April 12, 2004

Last Updated

August 15, 2024

Record last verified: 2022-02