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Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)
This study is currently recruiting participants.
Verified by IBSA Institut Biochimique SA, January 2009
First Received: January 22, 2009   No Changes Posted
Sponsored by: IBSA Institut Biochimique SA
Information provided by: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT00828191
  Purpose

Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.


Condition Intervention Phase
In Vitro Fertilization
Drug: Progesterone
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone 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 [ Time Frame: 10 weeks after treatment start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 4-5 weeks after treatment start ] [ Designated as safety issue: No ]
  • delivery rate [ Time Frame: nearly 9 months after treatment start ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Progesterone SC: Experimental Drug: Progesterone
25 mg, once a day, SC
Progesterone Tablets: Active Comparator Drug: Progesterone
100 mg, twice a day, vaginally

  Eligibility

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

Inclusion Criteria:

  • Patient has given written informed consent;
  • BMI < 30 kg/m2;
  • Age 18 - 42 (upon starting COH);
  • <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 polyps or protruding submucosal fibroids);
  • Patients must have at least three retrieved oocytes.

Exclusion Criteria:

  • Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
  • Stage III or IV endometriosis (no endometriomas);
  • Hydrosalpinges;
  • History of past poor response to COH resulting in canceling ART;
  • Use of thawed/donated oocytes;
  • Use of thawed/donated embryos;
  • Gestational carrier;
  • Patients affected by pathologies associated with any contraindication of being pregnant;
  • Hypersensitivity to study medication;
  • Uncontrolled adrenal or thyroid dysfunction;
  • History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product;
  • History of arterial disease;
  • Patients with hepatic impairment (liver function tests > 2x upper limits of normal);
  • Patients with dermatologic disease;
  • Patients with renal impairment (estimated creatinine clearance <60 mL/min/1.73 m2);
  • 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 in 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828191

Contacts
Contact: Clarence Jones, Dr. +1 (714) 8488084

Locations
United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Valerie L. Baker, M.D.            
Reproductive Partners Medical Group, Inc. Recruiting
Redondo Beach, California, United States, 90277
Contact: Bill Yee, M.D.            
Fertility Physicians of Northern California Recruiting
San Jose, California, United States, 95124
Contact: Karen Purcell, M.D.            
Fertility and Surgical Associates of California Recruiting
Thousand Oaks, California, United States, 91360
Contact: Gary Hubert, M.D.            
United States, Florida
Center for Reproductive Medicine Recruiting
Orlando, Florida, United States, 32804
Contact: Gary DeVane, M.D.            
United States, Idaho
Idaho Center for Reproductive Medicine Recruiting
Boise, Idaho, United States, 83702
Contact: Russell Foulk, M.D.            
United States, Texas
Center for Assisted Reproduction Recruiting
Bedford, Texas, United States, 76022
Contact: Kevin Doody, M.D.            
United States, Washington
Seattle Reproductive Medicine Recruiting
Seattle, Washington, United States, 98109
Contact: Michael R. Soules, M.D.            
Sponsors and Collaborators
IBSA Institut Biochimique SA
  More Information

No publications provided

Responsible Party: IBSA Institut Biochimique SA ( Clarence Jones )
Study ID Numbers: 07USA/Prg05
Study First Received: January 22, 2009
Last Updated: January 22, 2009
ClinicalTrials.gov Identifier: NCT00828191     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by IBSA Institut Biochimique SA:
Luteal support in IVF

Study placed in the following topic categories:
Progesterone
Hormone Antagonists
Progestins
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones

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

ClinicalTrials.gov processed this record on September 10, 2009