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)

Fertilization Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598208
• Other study ID #: P06055
• Secondary ID: 38826
• Status: Completed
• Phase: Phase 2
• Start date: May 19, 2003
• Est. completion date: March 15, 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: March 15, 2004
• Est. primary completion date: March 15, 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fertilization

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cumulus-oocyte-complexes retrieved		1 cycle
Secondary	Treatment failure rate		1 cycle