To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(Study 107012)(COMPLETED)(P05690)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00702845
First received: June 18, 2008
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation, using daily recFSH as a reference.


Condition Intervention Phase
Infertility
Drug: Org 36286 (corifollitropin alfa)
Drug: 150 IU recFSH (follitropin beta)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Equivalence Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of 100 µg Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Ovarian Stimulation Using Daily Recombinant FSH as Reference

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • The primary endpoint for the trial is number of oocytes retrieved. [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of recombinant FSH needed (total and from Day 8 to Day of hCG); Endocrinological parameters (FSH, LH, E2, P, inhibin-B); Number and size distribution of follicles as documented by ultrasonography during treatment and on the Day of hCG; [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
  • Number and quality of oocytes; Fertilization rate; Number and quality of embryos; Implantation rate; Miscarriage rate; Pregnancy rate [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]

Enrollment: 397
Study Start Date: January 2007
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
100 µg Org 36286 (corifollitropin alfa)
Drug: Org 36286 (corifollitropin alfa)

On day 2 or 3 of the menstrual cycle, a single subcutaneous (SC) injection of Org 36286 will be administered (Stimulation Day 1). Daily SC injections with placebo recFSH will be started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

From Stimulation Day 8 onwards treatment is continued with a daily SC dose of recFSH up to and including the Day of hCG.

The maximum total duration of stimulation is 19 days. The GnRH antagonist ganirelix (0.25 mg) should be administered once daily SC starting on Stimulation Day 5 up to and including the Day of hCG.

Other Name: Org 36286
Active Comparator: Arm 2
150 IU recFSH (follitropin beta)
Drug: 150 IU recFSH (follitropin beta)

On day 2 or 3 of the menstrual cycle, a single subcutaneous (SC) injection of placebo-Org 36286 will be administered (Stimulation Day 1). Daily SC injections with recFSH will be started on Stimulation Day 1 up to and including the Day of hCG. Total duration of stimulation is 19 days.

The GnRH antagonist ganirelix (0.25 mg) should be administered once daily SC starting on Stimulation Day 5 up to and including the Day of hCG.

Other Name: recFSH (Puregon/Follistim AQ Cartridge)

Detailed Description:

This is a randomized, double-blind, active-controlled, equivalence clinical trial investigating the efficacy and safety of a new treatment regimen with Org 36286, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in controlled ovarian stimulation for ART. For this regimen, patients receive a single injection of Org 36286 and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group patients receive daily injections of recFSH up to the day of triggering final oocyte maturation. Equivalence between the two treatment groups in the number of oocytes retrieved is the primary objective of this trial.

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females of couples with an indication for COS and IVF or ICSI;
  • >=18 and <= 36 years of age at the time of signing informed consent;
  • Body weight <= 60 kg and BMI >= 18 and <= 32 kg/m^2;
  • Normal menstrual cycle length: 24-35 days;
  • Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
  • Willing and able to sign informed consent.

Exclusion Criteria:

  • History of/or any current (treated) endocrine abnormality;
  • History of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS);
  • History of/or current polycystic ovary syndrome (PCOS);
  • More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5);
  • Less than 2 ovaries or any other ovarian abnormality (including endometrioma > 10 mm; visible on USS);
  • Presence of unilateral or bilateral hydrosalphinx (visible on USS);
  • Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >= 5 cm;
  • More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable);
  • History of non- or low ovarian response to FSH/hMG treatment;
  • History of recurrent miscarriage (3 or more, even when unexplained);
  • FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
  • Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
  • Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
  • Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
  • Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
  • Smoking more than 5 cigarettes per day;
  • History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
  • Previous use of Org 36286;
  • Use of hormonal preparations within 1 month prior to randomization;
  • Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol;
  • Administration of investigational drugs within three months prior to signing informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00702845     History of Changes
Other Study ID Numbers: 107012, EudraCT #: 2006-003811-36;, P05690
Study First Received: June 18, 2008
Last Updated: October 2, 2009
Health Authority: Austria: Federal Office for Safety in Health Care
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Spain: Ministry of Health and Consumption
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health

Keywords provided by Schering-Plough:
In vitro fertilization
Pharmacological effects of drugs
Hormones
Hormone Substitutes and Hormone Antagonists
Pharmacological Actions
Randomized
Multi-center
Multi-national
Double-blind
Active-controlled
Equivalence

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014