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A Phase 2, Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian (Study 38826)
This study has been completed.
First Received: January 10, 2008   Last Updated: July 28, 2008   History of Changes
Sponsored by: Organon
Information provided by: Organon
ClinicalTrials.gov Identifier: NCT00598208
  Purpose

The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.


Condition Intervention Phase
Fertilization
Drug: corifollitropin alfa
Drug: Follitropin beta injection
Phase II

Drug Information available for: Urofollitropin Follitropin beta Corifollitropin alfa Follicle Stimulating Hormone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 2, Open Label, Randomized Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or ICSI.

Further study details as provided by Organon:

Primary Outcome Measures:
  • Number of cumulus-oocyte-complexes retrieved [ Time Frame: 1 cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment failure rate [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]

Enrollment: 325
Study Start Date: May 2003
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
60 µg Org 36286 (corifollitropin alfa)
Drug: corifollitropin alfa
On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.
2: Experimental
120 µg Org 36286 (corifollitropin alfa)
Drug: corifollitropin alfa
On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.
3: Experimental
180 µg Org 36286 (corifollitropin alfa)
Drug: corifollitropin alfa
On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.
4: Active Comparator
Follitropin beta injection
Drug: Follitropin beta injection
Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females of couples with an indication for COH and IVF or ICSI;
  • >=18 and <=39 years of age at the time of signing informed consent;
  • BMI >=18 and <=29 kg/m^2;
  • Normal menstrual cycle length: 24-35 days;
  • Ejaculatory sperm (use of donated and/or frozen sperm is allowed);
  • Willing and able to sign informed consent.

Exclusion Criteria:

  • History of/or any current (treated) endocrine abnormality;
  • History of ovarian hyperstimulation syndrome (OHSS);
  • History of/or current polycystic ovary syndrome (PCOS) or current polycystic ovaries according to USS (at least 10 follicles of 2-8 mm in each ovary);
  • More than three unsuccessful COH cycles since the last established ongoing pregnancy (if applicable);
  • History of non- or low ovarian response to FSH/hMG treatment;
  • Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual cycle day 2-7) as measured by the local laboratory (FSH, LH, E2, P, total T, TSH and prolactin):
  • Any clinically relevant abnormal laboratory value;
  • Less than 2 ovaries;
  • Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
  • Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
  • Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease;
  • History of 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 Org 32489 (Puregon®) and/or Org 37462 (Orgalutran®) and/or Pregnyl® or any of their components;
  • Administration of investigational drugs within three months prior to signing informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598208

Sponsors and Collaborators
Organon
Investigators
Study Chair: Bernadette Mannearts, MSc Organon, part of Schering Plough
  More Information

No publications provided by Organon

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers: 38826
Study First Received: January 10, 2008
Last Updated: July 28, 2008
ClinicalTrials.gov Identifier: NCT00598208     History of Changes
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products;   Denmark: Danish Medicines Agency;   Finland: National Agency for Medicines;   Germany: Federal Institute for Drugs and Medical Devices;   Norway: Norwegian Medicines Agency;   Sweden: Medical Products Agency;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Organon:
In-vitro fertilization

Study placed in the following topic categories:
Ganirelix
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