Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)
Condition: In Vitro Fertilization
Intervention: Progesterone; Progesterone
Intervention description: 25 mg, once a day, SC; 100 mg, twice a day, vaginally
Intervention MeSH terms: Progesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 800.0
Sex: Female
Minimum age: 18 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Luteal support in IVF

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 < 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