Phase 3
N=1,509
A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)
In Vitro Fertilization
Bottom Line
View on ClinicalTrials.gov: NCT00696800 ↗Enrolled (actual)
1,509
Serious AEs
4.3%
Results posted
Aug 2014
Primary outcome: Primary: Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) — 39.0; 38.1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Corifollitropin alfa (Drug); RecFSH / Follitropin beta (Days 1 to 7) (Biological); Placebo Corifollitropin alfa (Drug); Placebo RecFSH / follitropin beta (Drug); RecFSH / Follitropin beta (Days 8 to hCG) (Biological); Ganirelix (Drug); hCG (Biological); Progesterone (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) |
39.0; 38.1 | — |
| PRIMARY Mean Number of Oocytes Retrieved |
13.8; 12.6 | 0.001 sig |
| SECONDARY Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1 |
400; 1800 | — |
| SECONDARY Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8 |
400; 400 | — |
| SECONDARY Serum FSH Levels During Stimulation |
6.70; 6.60; 23.49; 11.61; 11.76; 11.59 | — |
| SECONDARY Serum Luteinizing Hormone (LH) Levels During Stimulation |
4.80; 4.67; 3.62; 2.23; 1.29; 2.05 | — |
| SECONDARY Serum Estradiol (E2) Levels During Stimulation |
126.13; 124.79; 1859.39; 1392.97; 3700.92; 3750.96 | — |
| SECONDARY Serum Progesterone (P) Levels During Stimulation |
1.80; 1.85; 2.13; 1.61; 1.95; 2.64 | — |
| SECONDARY Serum Inhibin-B Levels During Stimulation |
52.78; 52.95; 488.54; 493.86; 578.21; 642.27 | — |
| SECONDARY Number of Follicles Categorized by Size on Stimulation Day 1 |
0.1; 0.1; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Number of Follicles Categorized by Size on Stimulation Day 5 |
4.4; 4.7; 0.3; 0.4; 0.1; 0.1 | — |
| SECONDARY Number of Follicles Categorized by Size on Stimulation Day 8 |
12.8; 11.6; 5.0; 5.2; 2.1; 2.5 | — |
| SECONDARY Number of Follicles Categorized by Size on the Day of hCG |
16.0; 13.9; 9.6; 8.7; 5.7; 5.6 | — |
| SECONDARY Number of Cumulus-oocyte-complexes |
13.6; 12.8 | — |
| SECONDARY Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI) |
13.8; 12.2; 1.1; 0.9; 10.8; 9.2 | — |
| SECONDARY Percentage of Fertilized Oocytes (Fertilization Rate) |
66.0; 67.6 | — |
| SECONDARY Number of Embryos Obtained on Day 3 Categorized by Quality |
8.4; 7.5; 4.7; 4.5; 2.6; 2.5 | — |
| SECONDARY Number of Embryos Transferred on Day 3 |
1.7; 1.7; 1.4; 1.4 | — |
| SECONDARY Percentage of Gestational Sacs (Implantation Rate) |
36.2; 32.2 | — |
| SECONDARY Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy |
8.4; 6.8 | — |
| SECONDARY Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy |
2.3; 2.0 | — |
| SECONDARY Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt |
48.1; 46.9 | — |
| SECONDARY Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer |
54.2; 50.0 | — |
Summary
To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in initiating multifollicular growth.
Eligibility Criteria
Inclusion Criteria
- Females of couples with an indication for Controlled Ovarian Stimulation (COS) and in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI);
- >=18 and 60 and =18 and 10 mm; visible on USS);
- Presence of unilateral or bilateral hydrosalphinx (visible on USS);
- Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >=5 cm;
- More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable);
- History of non- or low ovarian response to FSH/ human menopausal gonadotropin (hMG) treatment;
- History of recurrent miscarriage (3 or more, even when unexplained);
- FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
- Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
- Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
- Recent history of/or current epilepsy, human immunodeficiency virus (HIV) infection, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
- Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
- Smoking more than 5 cigarettes per day;
- History or 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 any of the concomitant medication prescribed as part of the treatment regimen in this protocol;
- Administration of investigational drugs within three months prior to signing informed consent.
Data sourced from ClinicalTrials.gov (NCT00696800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.