Progesterone for Infertility
(PROGRESS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires participants to stop taking certain medications that might interfere with the study, such as insulin sensitizing agents, vaginal medications, and any hormonal treatments other than those specified in the protocol. If you are taking any of these, you may need to stop them before starting the trial.
Is progesterone safe for use in humans?
How is the drug Progesterone-IBSA Injectable Solution unique for treating infertility?
What data supports the effectiveness of the drug Progesterone-IBSA Injectable Solution for infertility?
Are You a Good Fit for This Trial?
This trial is for premenopausal women aged 35-42 with a history of infertility, who have at least one euploid frozen blastocyst and less than three previous failed transfers. They must have normal menstrual cycles, not be breastfeeding or pregnant, and meet specific hormone levels. Exclusions include severe endometriosis, recurrent pregnancy loss, diabetes, liver/renal impairment, high grade cervical dysplasia, certain medication use within the last month.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active Progesterone-IBSA or Crinone 8% for luteal and early pregnancy support
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Monitoring of delivery outcomes and adverse events related to the mother and newborn
What Are the Treatments Tested in This Trial?
Interventions
- Progesterone-IBSA Injectable Solution
- Progesterone Vaginal Gel with Applicator
Progesterone-IBSA Injectable Solution is already approved in European Union, United States, Canada, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
IBSA Institut Biochimique SA
Lead Sponsor