680 Participants Needed

Progesterone for Infertility

(PROGRESS Trial)

Recruiting at 18 trial locations
BP
RS
Overseen ByR&D Scientific Affairs
Age: 18 - 65
Sex: Female
Trial Phase: Phase 3
Sponsor: IBSA Institut Biochimique SA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that progesterone, whether given as an injection or vaginally, is generally safe for use in supporting fertility treatments like IVF. Studies have compared different forms of progesterone and found them to be well-tolerated with manageable side effects.12345

How is the drug Progesterone-IBSA Injectable Solution unique for treating infertility?

Progesterone-IBSA Injectable Solution is unique because it combines the precise dosage of an injectable form with the comfort of a subcutaneous (under the skin) self-administration, avoiding the pain and complications of intramuscular injections and the discomfort of vaginal applications.36789

What data supports the effectiveness of the drug Progesterone-IBSA Injectable Solution for infertility?

Research shows that subcutaneous progesterone, like Progesterone-IBSA, is effective and safe for supporting the luteal phase in IVF treatments, which is crucial for successful embryo implantation and pregnancy.13459

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

Subject has given written informed consent
I am seeking IVF due to infertility, being single, or in a same-sex relationship.
Your body mass index (BMI) is less than 38 kg/m2.
See 14 more

Exclusion Criteria

I have a medical condition that prevents me from becoming pregnant.
I have a fibroid larger than 4 cm that changes the shape of my uterus or one that is over 5 cm.
My kidneys are not working well (low creatinine clearance).
See 23 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active Progesterone-IBSA or Crinone 8% for luteal and early pregnancy support

10 weeks
Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Long-term follow-up

Monitoring of delivery outcomes and adverse events related to the mother and newborn

2-4 weeks post expected delivery date

What Are the Treatments Tested in This Trial?

Interventions

  • Progesterone-IBSA Injectable Solution
  • Progesterone Vaginal Gel with Applicator
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: InvestigationalExperimental Treatment2 Interventions
Group II: ComparatorActive Control2 Interventions

Progesterone-IBSA Injectable Solution is already approved in European Union, United States, Canada, Switzerland for the following indications:

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Progesterone-IBSA for:
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Progesterone-IBSA for:
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Progesterone for:
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Progesterone for:
๐Ÿ‡จ๐Ÿ‡ญ
Approved in Switzerland as Progesterone for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

IBSA Institut Biochimique SA

Lead Sponsor

Trials
42
Recruited
10,300+

Published Research Related to This Trial

In a study of 65 IVF patients, aqueous subcutaneous progesterone (Prolutex) showed comparable efficacy to vaginal progesterone (Crinone) for luteal support, with clinical pregnancy rates of 25.0% for Prolutex and 33.3% for Crinone, indicating no significant difference.
While Prolutex was associated with more local injection site pain, it resulted in less vaginal discharge and vulvar discomfort, suggesting it may be a preferable option for some patients seeking different administration routes for progesterone during IVF.
Clinical use of aqueous subcutaneous progesterone compared with vaginal progesterone as luteal support in in vitro fertilization: A randomized controlled study in Taiwan.Kao, TC., Tu, YA., Yang, PK., et al.[2022]
In a meta-analysis of two phase III trials involving 1435 IVF patients, subcutaneous progesterone did not show any significant difference in ongoing pregnancy rates or live birth rates compared to vaginal progesterone.
Both methods of progesterone administration had similar safety profiles, with no significant differences in the risk of ovarian hyperstimulation syndrome (OHSS), indicating that subcutaneous progesterone is a viable alternative for luteal phase support in IVF.
Subcutaneous Progesterone Is Effective and Safe for Luteal Phase Support in IVF: An Individual Patient Data Meta-Analysis of the Phase III Trials.Doblinger, J., Cometti, B., Trevisan, S., et al.[2022]
In a study involving 683 assisted reproduction technology patients, subcutaneous progesterone (Prolutex) demonstrated noninferiority to vaginal progesterone gel (Crinone) in ongoing pregnancy rates, with rates of 27.4% for Prolutex and 30.5% for Crinone, indicating both treatments are similarly effective for luteal phase support.
Both Prolutex and Crinone showed equivalent delivery and live birth rates, and the safety profiles were comparable, suggesting that Prolutex is a safe and well-tolerated alternative to Crinone for supporting pregnancies in ART patients.
Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: a noninferiority randomized controlled study.Lockwood, G., Griesinger, G., Cometti, B.[2022]

Citations

1.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
Clinical use of aqueous subcutaneous progesterone compared with vaginal progesterone as luteal support in in vitro fertilization: A randomized controlled study in Taiwan. [2022]
Subcutaneous Progesterone Is Effective and Safe for Luteal Phase Support in IVF: An Individual Patient Data Meta-Analysis of the Phase III Trials. [2022]
Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: a noninferiority randomized controlled study. [2022]
Pharmaceutical and clinical development of a novel progesterone formulation. [2015]
A randomised comparison of side effects and patient inconvenience of two vaginal progesterone formulations used for luteal support in in vitro fertilisation cycles. [2022]
A randomized comparison of side effects and patient convenience between Cyclogest suppositories and Endometrin tablets used for luteal phase support in IVF treatment. [2022]
Patient attitudes towards and satisfaction with subcutaneous injection of progesterone versus vaginal administration in assisted reproductive technology treatment. [2023]
Use of progestogens in pregnant and infertile patients. [2012]
Clinical use of progesterone in infertility and assisted reproduction. [2015]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity