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Progesterone for Infertility (PROGRESS Trial)

Phase 3
Research Sponsored by IBSA Institut Biochimique SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premenopausal women 35 to 42 years of age at the time of consent (at least 35 [including day of birthday] and no more than 42 [up to the day before their 43rd birthday])
Hysterosalpingography, hysteroscopy, 3D ultrasound or sonohysterogram documenting a normal uterine cavity within the last year
Screening 3 weeks
Treatment Varies
Follow Up from 5 weeks post embryo transfer until the 12th week of pregnancy.
Awards & highlights

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.

Who is the study for?
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.Check my eligibility
What is being tested?
The study compares two forms of progesterone support for implantation after frozen embryo transfer: Progesterone-IBSA Injectable Solution versus Crinone Vaginal Gel. It's a multicenter trial where participants are randomly assigned to either treatment to assess which is more effective in supporting early pregnancy.See study design
What are the potential side effects?
Potential side effects from progesterone treatments can include abdominal pain or cramping, bloating, mood swings, headaches and breast tenderness. Some may experience injection site reactions with injectable solutions or vaginal irritation with gels.

PROGRESS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am a premenopausal woman aged 35 to 42.
My recent tests show a normal uterus.

PROGRESS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 5 weeks post embryo transfer until the 12th week of pregnancy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 5 weeks post embryo transfer until the 12th week of pregnancy. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical pregnancy rate
Ongoing pregnancy
Secondary outcome measures
Adverse Events related to the mother
Adverse events related to the newborn.
Cycle cancellation rate (with reason)
+8 more
Other outcome measures

PROGRESS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InvestigationalExperimental Treatment2 Interventions
Progesterone-IBSA 25mg, twice daily (BID) subcutaneous (SC) injection every 12 hours and Crinone Placebo, once daily (QD) intravaginally.
Group II: ComparatorActive Control2 Interventions
Crinone 8%, 90 mg, QD intravaginally and Progesterone-IBSA Placebo, BID SC Injection every 12 hours

Find a Location

Who is running the clinical trial?

IBSA Institut Biochimique SALead Sponsor
36 Previous Clinical Trials
9,277 Total Patients Enrolled
11 Trials studying Infertility
4,010 Patients Enrolled for Infertility

Media Library

Progesterone-IBSA Injectable Solution (Progestogen) Clinical Trial Eligibility Overview. Trial Name: NCT04549116 — Phase 3
Infertility Research Study Groups: Investigational, Comparator
Infertility Clinical Trial 2023: Progesterone-IBSA Injectable Solution Highlights & Side Effects. Trial Name: NCT04549116 — Phase 3
Progesterone-IBSA Injectable Solution (Progestogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04549116 — Phase 3
Infertility Patient Testimony for trial: Trial Name: NCT04549116 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
San Diego Fertility
Main Line Fertility
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

My husband and I had a ectopic pregnancy and we don’t know why. I was told that this is the first tome they have ever saw and ectopic abort itself without meds, surgery or patient dying.
PatientReceived 1 prior treatment
I have been trying for 25 cycles to become pregnant. I had a tubal reversal March 2022. My HSG test shows clear tubes and a normal uterus. I have tried letrozole. I ovulate normally. Normal, 28 day cycles.
PatientReceived 2+ prior treatments
I have tried many fertility treatments for the past 8 years. Nothing has worked for me. My fiance and I want to start our family together. It has been a financial burden on us because we have spent thousands of dollars without a positive outcome. Please allow me to join this trial in hopes that there will be a baby at the end.
PatientReceived no prior treatments
~93 spots leftby Sep 2024