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)(P06055)(COMPLETED)

NCT00598208 | Completed Phase 2

• 2 other identifiers: P0605538826
• Study Type: interventional
• Target: 325
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fertilization

Keywords

In-vitro fertilization

Outcome Measures

Primary Outcomes (1)

• Number of cumulus-oocyte-complexes retrieved

  1 cycle

Secondary Outcomes (1)

• Treatment failure rate

  1 cycle

Study Arms (4)

1

EXPERIMENTAL

60 µg Org 36286 (corifollitropin alfa)

Drug: corifollitropin alfa

2

EXPERIMENTAL

120 µg Org 36286 (corifollitropin alfa)

Drug: corifollitropin alfa

3

EXPERIMENTAL

180 µg Org 36286 (corifollitropin alfa)

Drug: corifollitropin alfa

4

ACTIVE COMPARATOR

Follitropin beta injection

Drug: Follitropin beta injection

Interventions

corifollitropin alfa DRUG

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.

Also known as: Org 36286

1; 2; 3

Follitropin beta injection DRUG

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.

Also known as: Follistim®, Puregon®

4

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (2)

• Zandvliet AS, Prohn M, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31.

  PMID: 26991902 DERIVED

• Corifollitropin Alfa Dose-finding Study Group. A randomized dose-response trial of a single injection of corifollitropin alfa to sustain multifollicular growth during controlled ovarian stimulation. Hum Reprod. 2008 Nov;23(11):2484-92. doi: 10.1093/humrep/den288. Epub 2008 Aug 6.

  PMID: 18684735 DERIVED

MeSH Terms

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; follitropin beta

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 21, 2008
• Study Start: May 19, 2003
• Primary Completion: March 15, 2004
• Study Completion: March 15, 2004
• Last Updated: August 15, 2024

Record last verified: 2022-02