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Progesterone for Infertility (PROGRESS Trial)
PROGRESS Trial Summary
This trialwill compare two treatments for helping infertile women become pregnant after frozen embryo transfer. It will look at safety and effectiveness of the treatments.
PROGRESS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPROGRESS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PROGRESS Trial Design
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Who is running the clinical trial?
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- I have a medical condition that prevents me from becoming pregnant.I am seeking IVF due to infertility, being single, or in a same-sex relationship.I have a fibroid larger than 4 cm that changes the shape of my uterus or one that is over 5 cm.Your body mass index (BMI) is less than 38 kg/m2.My kidneys are not working well (low creatinine clearance).I am a premenopausal woman aged 35 to 42.I have a hydrosalpinx that has not been surgically treated.I have or had a tumor that might respond to hormone therapy.You are allergic to progesterone or any ingredients in progesterone medications.I am experiencing vaginal bleeding that has not been diagnosed.I have a history of blood vessel problems like clots.I haven't taken any medication in the last month that could affect the study, except for levothyroxine.My condition is stage 3 or 4 endometriosis.Your body mass index (BMI) is less than 38 kg/m2.You have irregular or infrequent menstrual cycles with long gaps between periods.My recent tests show a normal uterus.I have or had an autoimmune disease like lupus.You have had two or more pregnancy losses in a row.I am eligible for IVF due to infertility, being single, or in a same-sex relationship.I have conditions that prevent me from using vaginal progesterone.I am using sperm that has been exposed to chemotherapy or collected through specific medical methods.I have been diagnosed with Type 1 or Type 2 diabetes.My liver tests are more than twice the normal limit.I have been diagnosed with severe cervical precancer.You have participated in another clinical trial or taken an experimental drug in the last 2 months.I do not have untreated issues in my uterus that could affect pregnancy.I will use the ERA test to decide the best day for my embryo transfer.The semen used for IVF was from ejaculation and the donor was 18-40 years old, following specific regulations.You are planning to use someone else's eggs or have someone else carry your baby for you.My family has a history of major birth defects.My adrenal or thyroid condition is not under control.
- Group 1: Investigational
- Group 2: Comparator
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could I be a candidate for this experiment?
"This clinical trial is testing a new fertility medication by enrolling 680 patients that fit the following description: between 35-42 years old, have a history of infertility, meet the Body Mass Index criteria, have had no more than 3 euploid blastocyst transfers without success, and have a normal uterine cavity."
Does this experiment have an age limit?
"Based on the study's eligibility requirements, patients aged 35 to 42 are able to participate. Out of the 72 total trials, this is one of 23 that isn't limited to seniors or minors."
What do researchers hope to learn from Investigational treatments?
"The drug 'Investigational' is given to patients with uterine hemorrhage. However, it has also been shown to mitigate the effects of hormonal imbalance, prevent recurrent cases of spontaneous preterm birth, and Endometrial Hyperplasia caused by conjugated estrogen."
What are the main goals of this clinical trial?
"This clinical trial will last for 5 weeks, during which time the success of the intervention in achieving ongoing pregnancy will be monitored. Additionally, local tolerability (defined as any reactions experienced at the injection site or in the genital area) and delivery rate will be noted. Finally, ectopic pregnancy rate will also be tracked."
Could you please list some other studies that have used Investigational drugs?
"45 trials are being conducted for the investigational stage, 8 of which are in Phase 3. Many of these trials have Barcelona, Catalunya as their location; however, there are 273 total sites running these types of clinical trials."
Are we still enrolling individuals for this experiment?
"The study is currently recruiting, according to the data on clinicaltrials.gov. This information was initially posted on October 12th, 2020 and was last updated November 10th, 2020."
In how many different medical clinics is this trial being run?
"There are a total of 15 different fertility clinics participating in this study. These include, but are not limited to: Care Fertility in Bedford, IVF Florida Reproductive Associates in Margate, and Kindbody located in Los Angeles."
Is there a danger to using Investigational medication?
"There is already some evidence of efficacy from earlier phases as well as multiple rounds of safety testing, so the Investigational drug receives a score of 3."
How many people are being chosen to participate in this research project?
"The sponsor, IBSA Institut Biochimique SA, needs to recruit 680 patients that match the clinical trial's inclusion criteria from different fertility clinics including Care Fertility in Bedford, Texas and IVF Florida Reproductive Associates in Margate, Florida."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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