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)

February 2, 2022 updated by: Organon and Co

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

259

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ganirelix
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.
Other Names:
  • Orgalutran®
  • Org 37462
Active Comparator: 2
triptorelin
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.
Other Names:
  • Decapeptyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At completion of ovarian stimulation; maximally after 18 days of recFSH administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 29, 2008

First Posted (Estimate)

July 30, 2008

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05703
  • 38651

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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