Phase 3
N=800
Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)
In Vitro Fertilization
Bottom Line
View on ClinicalTrials.gov: NCT00828191 ↗Enrolled (actual)
800
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Ongoing Pregnancy Rate — 40.8; 43.3 percentage of randomized patients — p=0.52
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
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ongoing Pregnancy Rate |
40.8; 43.3 | 0.52 |
| SECONDARY Implantation Rate |
33.2; 35.1 | 0.54 |
| SECONDARY Delivery Rate |
40.5; 42.5 | 0.62 |
Summary
Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.
Eligibility Criteria
Inclusion Criteria
- Patient has given written informed consent;
- BMI 1 cm;
- Stage III or IV endometriosis (no endometriomas);
- Hydrosalpinges;
- History of past poor response to COH resulting in canceling ART;
- Use of thawed/donated oocytes;
- Use of thawed/donated embryos;
- Gestational carrier;
- Patients affected by pathologies associated with any contraindication of being pregnant;
- Hypersensitivity to study medication;
- Uncontrolled adrenal or thyroid dysfunction;
- History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product;
- History of arterial disease;
- Patients with hepatic impairment (liver function tests > 2x upper limits of normal);
- Patients with dermatologic disease;
- Patients with renal impairment (estimated creatinine clearance <60 mL/min/1.73 m2);
- Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
- High grade cervical dysplasia;
- 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 in 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 (NCT00828191). 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.