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

In Vitro Fertilization Clinical Trial

Official title:

Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone for Luteal Phase Support in Patients Undergoing In Vitro Fertilization (IVF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828191
• Other study ID #: 07USA/Prg05
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2009
• Last updated: January 28, 2013
• Start date: December 2008
• Est. completion date: February 2012

Study information

• Verified date: January 2013
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: February 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• In Vitro Fertilization

Intervention

Drug:
• Progesterone
25 mg, once a day, SC
• Progesterone
100 mg, twice a day, vaginally

Locations

Country	Name	City	State
United States	Center for Assisted Reproduction	Bedford	Texas
United States	Idaho Center for Reproductive Medicine	Boise	Idaho
United States	Center for Reproductive Medicine	Orlando	Florida
United States	Reproductive Partners Medical Group, Inc.	Redondo Beach	California
United States	Fertility Physicians of Northern California	San Jose	California
United States	Seattle Reproductive Medicine	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California
United States	Fertility and Surgical Associates of California	Thousand Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing Pregnancy Rate		10 weeks after treatment start	No
Secondary	Implantation Rate	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.	4-5 weeks after treatment start	No
Secondary	Delivery Rate		nearly 9 months after treatment start	No