Current partner codePEPTIDESDE
NCT00598208·Phase 2·INTERVENTIONAL

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)

Status

Completed

Phase

Phase 2

Enrollment

325

Locations

0

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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.

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.

Timeline

From registration to results.

  1. First posted

    Jan 21, 2008

  2. Study start

    May 19, 2003

  3. Primary completion

    Mar 15, 2004

  4. Study completion

    Mar 15, 2004

  5. Results posted

    Not reported

  6. Registry updated

    Aug 15, 2024

Outcomes

What the study measures.

Primary outcomes

Number of cumulus-oocyte-complexes retrieved

Time frame · 1 cycle

Secondary outcomes

Treatment failure rate

Time frame · 1 cycle

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
39 Years
Sex
FEMALE
Healthy volunteers
No

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.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

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Put the record in context.

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