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)

Organon

Status and phase: Completed; Phase 2

Conditions: Fertilization

Treatments: Drug: corifollitropin alfa; Drug: Follitropin beta injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00598208

38826

P06055

Details and patient eligibility

About

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.

Enrollment: 325 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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325 participants in 4 patient groups

1

Experimental group

Description:

60 µg Org 36286 (corifollitropin alfa)

Treatment:

Drug: corifollitropin alfa

2

Experimental group

Description:

120 µg Org 36286 (corifollitropin alfa)

Treatment:

Drug: corifollitropin alfa

3

Experimental group

Description:

180 µg Org 36286 (corifollitropin alfa)

Treatment:

Drug: corifollitropin alfa

4

Active Comparator group

Description:

Follitropin beta injection

Treatment:

Drug: Follitropin beta injection