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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT00828191
First received: January 22, 2009
Last updated: January 28, 2013
Last verified: January 2013
  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 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 (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 ]
    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.

  • Delivery Rate [ Time Frame: nearly 9 months after treatment start ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: December 2008
Study Completion Date: February 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Progesterone SC Drug: Progesterone
25 mg, once a day, SC
Active Comparator: Progesterone Tablets 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, 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
  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: NCT00828191

Locations
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
  More Information

No publications provided

Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT00828191     History of Changes
Other Study ID Numbers: 07USA/Prg05
Study First Received: January 22, 2009
Results First Received: November 26, 2012
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

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

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 July 22, 2014