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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

January 22, 2009
January 28, 2013
January 2009
November 2010   (final data collection date for primary outcome measure)
Ongoing Pregnancy Rate at the End of the Study [ Time Frame: 10 weeks after treatment start ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00827983 on ClinicalTrials.gov Archive Site
  • 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.
Delivery rate and live birth rate; [ Time Frame: nearly 9 month after treatment start ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
In Vitro Fertilization
  • Drug: Progesterone
    25 mg, s.c., once à day
  • Drug: Progesterone
    90 mg, vaginally, once à day
  • Experimental: Progesterone SC
    Intervention: Drug: Progesterone
  • Active Comparator: Progesterone Vaginal gel
    Intervention: Drug: Progesterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
683
May 2011
November 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 42 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Hungary,   Italy,   Switzerland,   United Kingdom
 
NCT00827983
07EU/Prg06
Not Provided
IBSA Institut Biochimique SA
IBSA Institut Biochimique SA
Not Provided
Not Provided
IBSA Institut Biochimique SA
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP