Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
- Registration Number
- NCT00827983
- Lead Sponsor
- IBSA Institut Biochimique SA
- Brief Summary
Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 683
- Age 18- 42 (upon starting COH);
- BMI <30 kg/m2;
- <3 prior ART cycles (IVF, ICSI and related procedures);
- Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
- Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);
- At least 3 retrieved oocytes;
- Patient has given written informed consent.
- Intramural uterine fibroids that distort the uterine cavity or polyps >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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Progesterone SC Progesterone - Progesterone Vaginal gel Progesterone -
- Primary Outcome Measures
Name Time Method Ongoing Pregnancy Rate at the End of the Study 10 weeks after treatment start
- Secondary Outcome Measures
Name Time Method Delivery Rate and Live Birth Rate nearly 9 month after treatment start Implantation Rate Four to five weeks after oocytes retrieval Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.
Trial Locations
- Locations (14)
IIRM SA
🇨🇭Sorengo, Ticino, Switzerland
Universitätsfrauenklinik Basel
🇨🇭Basel, Switzerland
First Dept. Obstetric and Gynaecology, Semmelweiss University Faculty of Medicine
🇭🇺Budapest, Hungary
Klinik fur Frauenheilkunde und Geburthilfe - Universistät zu Lübeck
🇩🇪Lübeck, Germany
Clinica Mangiagalli, Università di Milano
🇮🇹Milano, Italy
Istituto Scientifico Universitario San Raffaele
🇮🇹Milan, Italy
Università degli Studi di Napoli 'Federico II
🇮🇹Naples, Italy
Ospedale Santa Chiara, Università degli studi di Pisa
🇮🇹Pisa, Italy
Midland Fertility Services
🇬🇧Aldridge, West Midlands, United Kingdom
The Bridge Center
🇬🇧London, United Kingdom
Unità Ospedaliera di Ginecologia e Ostetricia, Ospedale Civico Brunico
🇮🇹Brunico, Bolzano, Italy
Azienda Ospedaliero-Sanitaria di Modena
🇮🇹Modena, Italy
St. Bartholomew's Hospital - Center for Reproductive Medicine
🇬🇧London, United Kingdom
Guy's and St. Thomas' Hospital - Women's Health Department
🇬🇧London, United Kingdom