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 and Co325 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

325

Conditions

Fertilization

Interventions

corifollitropin alfaDRUG

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 injectionDRUG

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

Sex: FEMALEMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of cumulus-oocyte-complexes retrieved

Time frame: 1 cycle

Secondary Outcomes

Treatment failure rate

Time frame: 1 cycle

Data from ClinicalTrials.gov

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