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To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Engage)(Study 38819AM1)
This study has been completed.
First Received: June 11, 2008   Last Updated: June 13, 2008   History of Changes
Sponsored by: Organon
Information provided by: Organon
ClinicalTrials.gov Identifier: NCT00696800
  Purpose

To investigate the efficacy and safety of a single injection of 150 μg Org 36286 to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH as a reference.


Condition Intervention Phase
In Vitro Fertilization
 Drug: corifollitropin alfa
Drug: follitropin beta
 Phase III

Drug Information available for: Urofollitropin Follitropin beta Corifollitropin alfa Follicle Stimulating Hormone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III, Non-Inferiority Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of 150 µg Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Ovarian Stimulation Using Daily Recombinant FSH as Reference

Further study details as provided by Organon:

Primary Outcome Measures:
  • Ongoing pregnancy rate [ Time Frame: Assessed at least 10 weeks after embryo transfer ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Total and from Day 8 to Day of hCG ] [ Designated as safety issue: No ]
  • Endocrinological parameters (FSH, LH, E2, P, inhibin-B) [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
  • Number and size distribution of follicles as documented by ultrasonography [ Time Frame: during treatment and on the Day of hCG ] [ Designated as safety issue: No ]
  • Number and quality of oocytes [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
  • Fertilization rate [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
  • Number and quality of embryos [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
  • Implantation rate [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
  • Miscarriage rate [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: Yes ]
  • Pregnancy rate [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]

Enrollment: 1509
Study Start Date: July 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental
150 µg Org 36286 (corifollitropin alfa)
Drug: corifollitropin alfa

On day 2 or 3 of the menstrual cycle, a single SC injection of 150 μg (0.5 mL) Org 36286 will be administered (Stimulation Day 1). Daily SC injections with placebo-recFSH (equivalent of 200 IU fixed dose) 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.
Arm 2: Active Comparator
200 IU recFSH (follitropin beta)
Drug: follitropin beta

On day 2 or 3 of the menstrual cycle, a single SC injection of 0.5 mL placebo-Org 36286 will be administered (Stimulation Day 1). Daily SC injections with recFSH (200 IU fixed dose) 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.

Detailed Description:

This is a randomized, double-blind, active-controlled, non-inferiority 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.

Non-inferiority in ongoing pregnancy rates (assessed at least 10 weeks after embryo transfer) will be the primary endpoint for this trial. The number of oocytes retrieved will be analyzed as co-primary endpoint.

  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 and <=90 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers: 38819, EudraCT Number: 2004-004771-11
Study First Received: June 11, 2008
Last Updated: June 13, 2008
ClinicalTrials.gov Identifier: NCT00696800     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Organon:
Infertility
Pharmacological effect of drugs
Hormones
Hormone substitutes and hormone antagonists
Pharmacological actions
Randomized
 Multi-center
Multi-national
Double-blind
Active-controlled
Non-inferiority

Study placed in the following topic categories:
Infertility
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Follicle Stimulating Hormone

Additional relevant MeSH terms:
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Follicle Stimulating Hormone

ClinicalTrials.gov processed this record on May 07, 2009



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