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

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

• Registration Number: EUCTR2007-006595-11-HU
• Lead Sponsor: IBSA Institute Biochimique SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-02
• 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.

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