Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

In Vitro Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827983
• Other study ID #: 07EU/Prg06
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2009
• Last updated: January 28, 2013
• Start date: January 2009
• Est. completion date: May 2011

Study information

• Verified date: January 2013
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencySwitzerland: SwissmedicHungary: National Institute of PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 683
• Est. completion date: May 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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, sonohysterogram or hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);

• At least 3 retrieved oocytes;

• Patient has given written informed consent.

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;

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

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• In Vitro Fertilization

Intervention

Drug:
• Progesterone
25 mg, s.c., once à day
• Progesterone
90 mg, vaginally, once à day

Locations

Country	Name	City	State
Germany	Klinik fur Frauenheilkunde und Geburthilfe - Universistät zu Lübeck	Lübeck
Hungary	First Dept. Obstetric and Gynaecology, Semmelweiss University Faculty of Medicine	Budapest
Italy	Unità Ospedaliera di Ginecologia e Ostetricia, Ospedale Civico Brunico	Brunico	Bolzano
Italy	Istituto Scientifico Universitario San Raffaele	Milan
Italy	Clinica Mangiagalli, Università di Milano	Milano
Italy	Azienda Ospedaliero-Sanitaria di Modena	Modena
Italy	Università degli Studi di Napoli 'Federico II	Naples
Italy	Ospedale Santa Chiara, Università degli studi di Pisa	Pisa
Switzerland	Universitätsfrauenklinik Basel	Basel
Switzerland	IIRM SA	Sorengo	Ticino
United Kingdom	Midland Fertility Services	Aldridge	West Midlands
United Kingdom	Guy's and St. Thomas' Hospital - Women's Health Department	London
United Kingdom	St. Bartholomew's Hospital - Center for Reproductive Medicine	London
United Kingdom	The Bridge Center	London

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Countries where clinical trial is conducted

Germany,  Hungary,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing Pregnancy Rate at the End of the Study		10 weeks after treatment start	No
Secondary	Delivery Rate and Live Birth Rate		nearly 9 month after treatment start	No
Secondary	Implantation Rate	Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.	Four to five weeks after oocytes retrieval	No