Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IBSA Institut Biochimique SA
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.