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Progestogen
Progesterone for Infertility (PROGRESS Trial)
Phase 3
Recruiting
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
Must not have
Contraindication to pregnancy (i.e. an active, uncontrolled clinically significant medical condition or abnormality of the sexual organs determined by the provider)
Presence of a submucosal or intramural fibroid > 4 cm which distorts the uterine cavity or are > 5 cm in diameter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 5 weeks post embryo transfer until the 12th week of pregnancy.
Awards & highlights
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a premenopausal woman aged 35 to 42.
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My recent tests show a normal uterus.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a medical condition that prevents me from becoming pregnant.
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I have a fibroid larger than 4 cm that changes the shape of my uterus or one that is over 5 cm.
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My kidneys are not working well (low creatinine clearance).
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I have a hydrosalpinx that has not been surgically treated.
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I am experiencing vaginal bleeding that has not been diagnosed.
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I have a history of blood vessel problems like clots.
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My condition is stage 3 or 4 endometriosis.
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I have or had an autoimmune disease like lupus.
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I have conditions that prevent me from using vaginal progesterone.
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I am using sperm that has been exposed to chemotherapy or collected through specific medical methods.
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I have been diagnosed with Type 1 or Type 2 diabetes.
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My liver tests are more than twice the normal limit.
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I have been diagnosed with severe cervical precancer.
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I do not have untreated issues in my uterus that could affect pregnancy.
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My family has a history of major birth defects.
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My adrenal or thyroid condition is not under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 5 weeks post embryo transfer until the 12th week of pregnancy.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 5 weeks post embryo transfer until the 12th week of pregnancy.
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 moreOther outcome measures
Progesterone
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational
- Group 2: Comparator
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Infertility Patient Testimony for trial: Trial Name: NCT04549116 — Phase 3
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