This is a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority clinical study in women aged 35 to 42 years. This study will investigate the safety and efficacy of Progesterone-IBSA to support euploid embryo blastocyst implantation and early pregnancy after frozen embryo transfer (FET) in a modified natural cycle as a treatment for infertile women. Subjects will be randomized to receive either active Progesterone-IBSA or Crinone 8% for luteal and early pregnancy support and these two groups will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
680
Progesterone-IBSA 25mg, twice daily (BID) SC Injection every 12 hours
Crinone 8%, 90 mg, QD intravaginally
Vaginal gel Placebo, once daily (QD) intravaginally
The Fertility Treatment Center, LLC
Tempe, Arizona, United States
Clinical pregnancy rate
defined by the presence of an intrauterine fetal heart beat
Time frame: 5 weeks post-embryo transfer
Ongoing pregnancy
defined by the presence of an ongoing intrauterine pregnancy with fetal heart beat
Time frame: 10 weeks post-embryo transfer
Positive pregnancy rate
positive serum β-human chorionic gonadotropin (hCG) test rate
Time frame: 10+/-2 days after embryo transfer.
Implantation rate
defined by the number of gestational sacs observed at Visit 6 by means of a transvaginal ultrasound (TVUS), divided by the number of blastocysts transferred (%)
Time frame: 6 weeks after embryo transfer,
Delivery rate
defined as the number of deliveries with at least one live birth or stillbirth (%)
Time frame: 2-4 weeks post expected delivery date.
Live birth rate
defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life
Time frame: 2-4 weeks post expected delivery date.
Cycle cancellation rate (with reason)
defined as number of subjects dropping form the study at any time.
Time frame: from treatment start until 10 weeks of pregnancy
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Placebo injectable solution, BID SC Injection every 12 hours
HRC Fertility
Encino, California, United States
Kindbody
Los Angeles, California, United States
San Diego Fertility
San Diego, California, United States
Spring Fertility
San Francisco, California, United States
Illume Fertility
Norwalk, Connecticut, United States
Reproductive Associates of Delaware
Newark, Delaware, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
IVF Florida Reproductive Associates
Margate, Florida, United States
The IVF Center
Winter Park, Florida, United States
...and 12 more locations
Adverse Events related to the mother
frequency and severity of adverse events related to the mother.
Time frame: from Informed consent signature until 2-4 week after delivery.
Local tolerability
At each visit, the subject will be queried about the presence of local reactions at administration site (pain, redness, swelling and itching at injection site and pain, irritation, swelling and leakage in the genital area). Events will be described in term of nature, severity (mild, moderate, severe, or very severe) and duration (persisted for up to 1 hour, persisted for more than 1 up to 4 hours, persisted for more than 4 up to 12 hours, persisted for more than 12 hours).
Time frame: from the 4th day of treatment administration until 10 weeks post embryo transfer.
Early Miscarriage rate
defined as a spontaneous loss of an intra-uterine pregnancy
Time frame: from 5 weeks post embryo transfer until the 12th week of pregnancy.
Late miscarriage rate
defined as a spontaneous loss of an intra-uterine pregnancy
Time frame: after the 12th week of pregnancy until delivery.
Ectopic pregnancy rate
defined as a pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology.
Time frame: from 5 weeks post embryo transfer until the 12th week of pregnancy.
Adverse events related to the newborn.
frequency and severity of adverse events related to the newborn.
Time frame: 2-4 weeks after expected delivery.