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Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00828191
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : December 26, 2012
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

Brief Summary:
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 or disease Intervention/treatment Phase
In Vitro Fertilization Drug: Progesterone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone for Luteal Phase Support in Patients Undergoing In Vitro Fertilization (IVF)
Study Start Date : December 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Progesterone SC Drug: Progesterone
25 mg, once a day, SC

Active Comparator: Progesterone Tablets Drug: Progesterone
100 mg, twice a day, vaginally

Primary Outcome Measures :
  1. Ongoing Pregnancy Rate [ Time Frame: 10 weeks after treatment start ]

Secondary Outcome Measures :
  1. Implantation Rate [ Time Frame: 4-5 weeks after treatment start ]
    Implantation rate was defined as the number of gestational sacs divided by the number of embryos transferred (%). This value was calculated for all the patients who had at least one embryo transferred.

  2. Delivery Rate [ Time Frame: nearly 9 months after treatment start ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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, sonohysterogram 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00828191

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United States, California
Reproductive Partners Medical Group, Inc.
Redondo Beach, California, United States, 90277
Fertility Physicians of Northern California
San Jose, California, United States, 95124
Stanford University Medical Center
Stanford, California, United States, 94305
Fertility and Surgical Associates of California
Thousand Oaks, California, United States, 91360
United States, Florida
Center for Reproductive Medicine
Orlando, Florida, United States, 32804
United States, Idaho
Idaho Center for Reproductive Medicine
Boise, Idaho, United States, 83702
United States, Texas
Center for Assisted Reproduction
Bedford, Texas, United States, 76022
United States, Washington
Seattle Reproductive Medicine
Seattle, Washington, United States, 98109
Sponsors and Collaborators
IBSA Institut Biochimique SA

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: IBSA Institut Biochimique SA Identifier: NCT00828191     History of Changes
Other Study ID Numbers: 07USA/Prg05
First Posted: January 23, 2009    Key Record Dates
Results First Posted: December 26, 2012
Last Update Posted: January 31, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs