Phase 3
N=1,332
Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT00565747 ↗Enrolled (actual)
1,332
Serious AEs
1.6%
Results posted
Nov 2013
Primary outcome: Primary: Ongoing Implantation Rate Week 7 — 23.5; 20.0 percentage of transferred embryos
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Test culture (Device); Control culture (Device)
- Age
- Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Origio A/S
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ongoing Implantation Rate Week 7 |
23.5; 20.0 | — |
| SECONDARY Number of Top Quality Embryos (TQE´s) |
15.6; 16.8 | — |
| SECONDARY Live Birth |
28.9; 24.1 | — |
Summary
This study is to assess whether addition of 2 ng/ml GM-CSF into a specific culture medium will increase the chance of a pregnancy after in vitro fertilisation.
Eligibility Criteria
Inclusion Criteria
- The couple or single woman has signed an informed consent form before any trial-related activities.
- In Vitro Fertilization (IVF) or IntraCytoplasmic Sperm Injection (ICSI) treatment indicated
- 25-39 years of age (both inclusive)
- Regular menstrual cycle: 21-35 days (both inclusive)
- Women treated with a standard Gonadotropin-Releasing Hormone (GnRH) agonist or antagonist protocol and a Follicle Stimulating Hormone (FSH) / human Menopausal Gonadotropin (hMG) starting dose between 100 and 300 IU daily.
- human Chorionic Gonadotropin (hCG) administration when the leading follicle has a calculated diameter of minimum 17 mm, or the day after.
- At least 3 follicles with a calculated diameter of ≥ 14 mm at the day of hCG.
Exclusion Criteria
- The woman has previously participated in the DK001 study.
- Use of assisted hatching.
- Indication for Testicular Sperm Aspiration (TESA) or Percutaneous Epididymal Sperm Aspiration (PESA)
- Any medical conditions or genetic disorders prohibiting IVF/ICSI or interfering with the interpretation of results of the study (including pre-implantation genetic diagnostics).
- Use of any investigational drug within 30 days before oocyte retrieval
- Any severe chronic disease of relevance for reproductive function.
- Oocyte donation patients (donor or recipient).
Data sourced from ClinicalTrials.gov (NCT00565747). 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.