Status:
COMPLETED
Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
Lead Sponsor:
IBSA Institut Biochimique SA
Conditions:
In Vitro Fertilization
Eligibility:
FEMALE
18-42 years
Phase:
PHASE3
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
683 Patients enrolled
Trial Details
Trial ID
NCT00827983
Start Date
January 1 2009
End Date
May 1 2011
Last Update
January 31 2013
Active Locations (14)
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1
Klinik fur Frauenheilkunde und Geburthilfe - Universistät zu Lübeck
Lübeck, Germany, 23538
2
First Dept. Obstetric and Gynaecology, Semmelweiss University Faculty of Medicine
Budapest, Hungary, 1088
3
Unità Ospedaliera di Ginecologia e Ostetricia, Ospedale Civico Brunico
Bruneck, Bolzano, Italy, 39031
4
Istituto Scientifico Universitario San Raffaele
Milan, Milan, Italy, 20132