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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT00827983
First received: January 22, 2009
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
In Vitro Fertilization
Drug: Progesterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

Resource links provided by NLM:


Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • Ongoing Pregnancy Rate at the End of the Study [ Time Frame: 10 weeks after treatment start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delivery Rate and Live Birth Rate [ Time Frame: nearly 9 month after treatment start ] [ Designated as safety issue: No ]
  • Implantation Rate [ Time Frame: Four to five weeks after oocytes retrieval ] [ Designated as safety issue: No ]
    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.


Enrollment: 683
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Progesterone SC Drug: Progesterone
25 mg, s.c., once à day
Active Comparator: Progesterone Vaginal gel Drug: Progesterone
90 mg, vaginally, once à day

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827983

Locations
Germany
Klinik fur Frauenheilkunde und Geburthilfe - Universistät zu Lübeck
Lübeck, Germany, 23538
Hungary
First Dept. Obstetric and Gynaecology, Semmelweiss University Faculty of Medicine
Budapest, Hungary, 1088
Italy
Unità Ospedaliera di Ginecologia e Ostetricia, Ospedale Civico Brunico
Brunico, Bolzano, Italy, 39031
Istituto Scientifico Universitario San Raffaele
Milan, Italy, 20132
Clinica Mangiagalli, Università di Milano
Milano, Italy, 20122
Azienda Ospedaliero-Sanitaria di Modena
Modena, Italy, 41100
Università degli Studi di Napoli 'Federico II
Naples, Italy, 80131
Ospedale Santa Chiara, Università degli studi di Pisa
Pisa, Italy, 56100
Switzerland
IIRM SA
Sorengo, Ticino, Switzerland, 6924
Universitätsfrauenklinik Basel
Basel, Switzerland, 4031
United Kingdom
Midland Fertility Services
Aldridge, West Midlands, United Kingdom, WS9 8LT
Guy's and St. Thomas' Hospital - Women's Health Department
London, United Kingdom, SE1 9RT
St. Bartholomew's Hospital - Center for Reproductive Medicine
London, United Kingdom, EC1A 7BE
The Bridge Center
London, United Kingdom, SE1 9RY
Sponsors and Collaborators
IBSA Institut Biochimique SA
  More Information

No publications provided

Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT00827983     History of Changes
Other Study ID Numbers: 07EU/Prg06
Study First Received: January 22, 2009
Results First Received: November 26, 2012
Last Updated: January 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Switzerland: Swissmedic
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by IBSA Institut Biochimique SA:
Luteal Phase Support in IVF patients

Additional relevant MeSH terms:
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014