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Ensure: Corifollitropin Alfa vs Daily recFSH in Women ≤60 kg

NCT00702845Phase 3

Key facts

Status: Completed
Start: Dec 2006
Primary completion: Jul 2007
Sponsor: Organon & Co.
Modality: rProtein (Recombinant Protein), Hormone, Biologic

Drugs: corifollitropin alfa
Conditions: infertility

Overview

Phase 3, randomised, double-blind trial of corifollitropin alfa in infertility (2 arms), sponsored by Organon & Co. Primary endpoint: Number of Cumulus-oocyte-complexes Retrieved, Per Attempt up to 21 days. Started Dec 2006; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

corifollitropin alfa 100 µg
Single dose corifollitropin alfa 100 µg
recFSH 150 IU
Daily recFSH 150 IU

Who it enrols

Women aged 18-36 weighing ≤60 kg with a normal menstrual cycle and indication for COS/IVF/ICSI. Excludes PCOS, severe endometriosis, hydrosalpinx, recurrent miscarriage, and endocrine abnormalities.

Endpoints

Primary

Number of Cumulus-oocyte-complexes Retrieved, Per Attemptup to 21 days

Secondary

Total Dose of recFSH Administeredup to 19 days
Total Duration of Stimulationup to 19 days
Serum Follicle Stimulating Hormone (FSH) Levelsup to 6 weeks
Serum Lutenizing Hormone (LH) Levelsup to 6 weeks
Serum Estradiol (E2) Levelsup to 6 weeks
Serum Progesterone (P) Levelsup to 6 weeks
Serum Inhibin-B Levelsup to 6 weeks
Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administrationup to 19 days

Results

Primary endpoints met

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