Phase 3
N=683
Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
In Vitro Fertilization
Bottom Line
View on ClinicalTrials.gov: NCT00827983 ↗Enrolled (actual)
683
Serious AEs
5.0%
Results posted
Dec 2012
Primary outcome: Primary: Ongoing Pregnancy Rate at the End of the Study — 27.4; 30.5 percentage of randomized patient — p=0.37
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Progesterone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- IBSA Institut Biochimique SA
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ongoing Pregnancy Rate at the End of the Study |
27.4; 30.5 | 0.37 |
| SECONDARY Delivery Rate and Live Birth Rate |
26.8; 29.9 | 0.37 |
| SECONDARY Implantation Rate |
22.6; 23.1 | 0.85 |
Summary
Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).
Eligibility Criteria
Inclusion Criteria
- Age 18- 42 (upon starting COH);
- BMI 1 cm;
- Stage III or IV endometriosis (endometriomas);
- Hydrosalpinx;
- History of past poor response to COH resulting in canceling ART;
- Use of thawed/donated oocytes;
- Use of thawed/donated embryos;
- Patients affected by pathologies associated with any contraindication of being pregnant;
- Hypersensitivity to study medication;
- Uncontrolled adrenal or thyroid dysfunction;
- Undiagnosed vaginal bleeding;
- History of arterial disease;
- Patients with hepatic impairment;
- Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
- High grade cervical dysplasia;
- Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
- History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages wherein pregnancy developed to a minimum of a gestational sac on TVUS;
- Participation in a concurrent clinical trial or another trial within the past 2 months;
- Use of concomitant medications that might interfere with the study evaluation;
- Pre-implantation genetic diagnosis/screening.
Data sourced from ClinicalTrials.gov (NCT00827983). 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.