Phase 3
N=397
To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT00702845 ↗Enrolled (actual)
397
Serious AEs
7.3%
Results posted
Apr 2015
Primary outcome: Primary: Number of Cumulus-oocyte-complexes Retrieved, Per Attempt — 13.3; 10.6 Number of cumulus-oocyte-complexes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- corifollitropin alfa (Org 36286) (Drug); recFSH (follitropin beta) (Drug); gonadatropin releasing hormone (GnRH) antagonist (ganirelix) (Drug); human chorion gonadatropin (hCG) (Drug); progesterone (Biological); placebo-recFSH (follitropin alfa) (Drug); placebo-corifollitropin alfa (Drug); open-label recFSH (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Cumulus-oocyte-complexes Retrieved, Per Attempt |
13.3; 10.6 | <0.001 sig |
| SECONDARY Total Dose of recFSH Administered |
300.0; 1350.0 | — |
| SECONDARY Total Dose of recFSH Administered From Day 8 Onwards |
300.0; 275.0 | — |
| SECONDARY Number of Days Treated With recFSH |
2.0; 9.0 | — |
| SECONDARY Total Duration of Stimulation (Days) |
9.0; 9.0 | — |
| SECONDARY Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection) |
6.46; 6.51; 26.30; 9.18; 19.50; 10.20 | — |
| SECONDARY Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection) |
4.46; 4.12; 1.18; 1.46; 1.91; 1.49 | — |
| SECONDARY Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection) |
118.17; 120.38; 803.73; 506.46; 1901.06; 1295.51 | — |
| SECONDARY Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection) |
1.36; 1.40; 1.23; NA; 1.65; 1.28 | — |
| SECONDARY Serum Inhibin-B Levels (Restricted to Participants With hCG Injection) |
54.20; 57.80; 351.00; 259.00; 598.00; 489.00 | — |
| SECONDARY Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only) |
12.7; 9.9; 0.8; 0.7; 10.7; 7.8 | — |
| SECONDARY Fertilization Rate |
67.6; 67.7 | — |
| SECONDARY Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI) |
7.2; 6.2; 3.4; 3.0; 1.7; 1.4 | — |
| SECONDARY Implantation Rate for Participants With ET |
23.6; 28.5 | — |
| SECONDARY Number of Participants With Miscarriages |
10; 4; 1; 1 | — |
| SECONDARY Number of Participants With Pregnancies |
101; 58; 101; 58; 78; 48 | — |
Summary
Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.
Eligibility Criteria
Inclusion Criteria
- Females of couples with an indication for COS and IVF or ICSI;
- >=18 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/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, 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 (NCT00702845). 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.