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

Completed · Phase 3

Conditions studied: In Vitro Fertilization

In brief

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.

Key facts

Study ID

NCT00828191

Run by

IBSA Institut Biochimique SA

People needed

800

Starts

2008-12-01

Expected to finish

2012-02-01

Last updated by the study team

2013-01-31

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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