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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
800
25 mg, once a day, SC
100 mg, twice a day, vaginally
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
Ongoing Pregnancy Rate
Time frame: 10 weeks after treatment start
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.
Time frame: 4-5 weeks after treatment start
Delivery Rate
Time frame: nearly 9 months after treatment start
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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