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

• Conditions: Patient undergoing in-Vitro Fertilization (IVF); MedDRA version: 9.1Level: LLTClassification code 10021572Term: In vitro fertilization

• Registration Number: EUCTR2007-006595-11-DE
• Lead Sponsor: IBSA Institut Biochimique SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-23
• Last Update Posted: 7 August 2012

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:
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 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;
-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: Efficacy of Subcutaneous Progesterone (IBSA) versus Vaginal Progesterone Gel (Crinone) for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF).;Secondary Objective: Tolerability of Subcutaneous Progesterone (IBSA) versus Vaginal Progesterone Gel (Crinone) for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF).;Primary end point(s): Ongoing pregnancy rate at the end of the study (10 weeks of luteal support).