Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) versus Vaginal Progesterone Gel (Crinone) for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF).

• Conditions: uteal phase support in patients undergoing Assisted Reproductive Technology (IVF).; MedDRA version: 14.1Level: PTClassification code 10021926Term: InfertilitySystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2007-006595-11-IT
• Lead Sponsor: IBSA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-01
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 672

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, sonohystogram or hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid); - At least 3 retrieved oocytes; - Patient has given written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 cancelling 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; 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. - Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy 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 Crinone administered intravaginally at 90 mg daily.;Secondary Objective: to evaluate the tolerability of the product;Primary end point(s): Ongoing pregnancy rate at the end of the study (10 weeks of luteal support).