← Back to Search

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

Pivotal 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.

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.

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 below

Select...

I am a premenopausal woman aged 35 to 42.

Select...

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.

Select...

I have a fibroid larger than 4 cm that changes the shape of my uterus or one that is over 5 cm.

Select...

My kidneys are not working well (low creatinine clearance).

Select...

I have a hydrosalpinx that has not been surgically treated.

Select...

I am experiencing vaginal bleeding that has not been diagnosed.

Select...

I have a history of blood vessel problems like clots.

Select...

My condition is stage 3 or 4 endometriosis.

Select...

I have or had an autoimmune disease like lupus.

Select...

I have conditions that prevent me from using vaginal progesterone.

Select...

I am using sperm that has been exposed to chemotherapy or collected through specific medical methods.

Select...

I have been diagnosed with Type 1 or Type 2 diabetes.

Select...

My liver tests are more than twice the normal limit.

Select...

I have been diagnosed with severe cervical precancer.

Select...

I do not have untreated issues in my uterus that could affect pregnancy.

Select...

My family has a history of major birth defects.

Select...

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.

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.