Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

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

Criteria

Inclusion Criteria:

• Patient has given written informed consent;

• BMI < 30 kg/m2;

• Age 18 - 42 (upon starting COH);

• <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 polyps or protruding submucosal fibroids);

• Patients must have at least three retrieved oocytes.

Exclusion Criteria:

• Intramural uterine fibroids that distort the uterine cavity or polyps >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