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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-006595-11-DE

Enrollment

672

Registered

2008-06-23

Start date

2008-09-25

Completion date

Unknown

Last updated

2012-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient undergoing in-Vitro Fertilization (IVF) MedDRA version: 9.1 Level: LLT Classification code 10021572 Term: In vitro fertilization

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: progesterone CAS Number: 57-83-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 18- 42 (upon starting COH); - BMI =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Germany, Hungary, Italy, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026