Progesterone for Infertility (PROGRESS Trial)
Recruiting in Palo Alto (17 mi)
+18 other locations
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: IBSA Institut Biochimique SA
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 5 jurisdictions
Trial Summary
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.
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.
35689Is 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.
12478What 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.
14578Will 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.
Eligibility Criteria
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
I am a premenopausal woman aged 35 to 42.
My recent tests show a normal uterus.
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).
I have a hydrosalpinx that has not been surgically treated.
I am experiencing vaginal bleeding that has not been diagnosed.
I have a history of blood vessel problems like clots.
My condition is stage 3 or 4 endometriosis.
I have or had an autoimmune disease like lupus.
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.
I do not have untreated issues in my uterus that could affect pregnancy.
My family has a history of major birth defects.
My adrenal or thyroid condition is not under control.
Participant Groups
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.
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
Progesterone-IBSA Injectable Solution is already approved in European Union, United States, United States, Canada, Switzerland for the following indications:
🇪🇺 Approved in European Union as Progesterone-IBSA for:
- Infertility
- Luteal phase support
🇺🇸 Approved in United States as Progesterone-IBSA for:
- Investigational for luteal phase support and early pregnancy support
🇺🇸 Approved in United States as Progesterone for:
- Contraception
- Control of abnormal uterine bleeding
- Maintenance of pregnancy
- Prevention of endometrial hyperplasia
🇨🇦 Approved in Canada as Progesterone for:
- Contraception
- Control of abnormal uterine bleeding
- Maintenance of pregnancy
- Prevention of endometrial hyperplasia
🇨🇭 Approved in Switzerland as Progesterone for:
- Contraception
- Control of abnormal uterine bleeding
- Maintenance of pregnancy
- Prevention of endometrial hyperplasia
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
KindbodyLos Angeles, CA
Carolina ConceptionsRaleigh, NC
Center of Reproductive Medicine, LLC., Shady Grove FertilityWebster, TX
IVF Florida Reproductive AssociatesMargate, FL
More Trial Locations
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Who is running the clinical trial?
IBSA Institut Biochimique SALead Sponsor
References
A randomised comparison of side effects and patient inconvenience of two vaginal progesterone formulations used for luteal support in in vitro fertilisation cycles. [2022]To compare side effects and patient inconvenience of two vaginal progesterone (P) formulations for luteal support in in vitro fertilisation cycles.
A randomized comparison of side effects and patient convenience between Cyclogest suppositories and Endometrin tablets used for luteal phase support in IVF treatment. [2022]This study compared side effects and patient convenience of vaginal progesterone suppositories (Cyclogest) and vaginal progesterone tablets (Endometrin) used for luteal phase support in in vitro fertilization/embryo transfer (IVF/ET) cycles using pituitary downregulation.
Use of progestogens in pregnant and infertile patients. [2012]Progesterone is an essential hormone in the occurence and maintenance of pregnancy. Natural or synthetic progestogens are commonly used in pregnant patients or patients undergoing infertility treatments for various indications. Most frequently put indications for the use of progestogens in these patient populations are the prevention of spontaneous preterm birth, the prevention of pregnancy loss in pregnancies with an unexplained recurrent pregnancy loss and in patients with threatened abortion. It is also used in pregnant women undergoing nonobstetric surgery, for infertility or recurrent pregnancy loss that is thought to be due to luteal phase defect or as a luteal support in stimulated IVF cycles. We aimed to review the current evidence for the use of progestogens in each of these settings.
Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: a noninferiority randomized controlled study. [2022]To compare the safety, efficacy, and tolerability of subcutaneous progesterone (Prolutex, 25 mg; IBSA Institut Biochimique SA) with vaginal progesterone gel (Crinone, 8%; Merck Serono) for luteal phase support (LPS) in assisted reproduction technologies (ART) patients.
Pharmaceutical and clinical development of a novel progesterone formulation. [2015]Progesterone plays an essential role in reproductive events. Its use for luteal support in patients undergoing infertility treatment is an established practice. The different routes used to administer progesterone impact on its efficacy in luteal support: oral administration has been shown to be ineffective due to an extensive first-pass metabolism in the liver; vaginal application has a good efficacy but has drawbacks such as vaginal leakage, irritation, discomfort and uncertainty about the real dose adsorbed; finally, intramuscular administration ensures a precise dosage but can be extremely painful with, in some cases, formation of sterile abscesses. A new progesterone preparation is now available in several European and extra-European countries that combines the precise dosage of the injectable formulation with the comfort of a well-tolerated subcutaneous self-administration. The pharmacokinetic and pharmacodynamic properties of this new product are reviewed here, together with the clinical evidence obtained in two multicenter randomized clinical trials.
Clinical use of progesterone in infertility and assisted reproduction. [2015]Progesterone is essential in establishing and maintaining early pregnancy. This article discusses the clinical applications of progesterone in reproductive medicine and in the management of infertile patients, focusing on the different available formulations of this drug.
Subcutaneous Progesterone Is Effective and Safe for Luteal Phase Support in IVF: An Individual Patient Data Meta-Analysis of the Phase III Trials. [2022]To summarize efficacy and safety data on a new progesterone compound which is available for subcutaneous administration as compared to vaginally administered progesterone for luteal phase support in patients undergoing IVF treatment.
Clinical use of aqueous subcutaneous progesterone compared with vaginal progesterone as luteal support in in vitro fertilization: A randomized controlled study in Taiwan. [2022]This study aims to compare the efficacy, tolerability and patient satisfaction between aqueous subcutaneous progesterone (Prolutex, 25 mg/vial; IBSA) and vaginal progesterone (Crinone, 90 mg/tube; Merck) as luteal support for fresh embryo transfers in in-vitro fertilization (IVF).
Patient attitudes towards and satisfaction with subcutaneous injection of progesterone versus vaginal administration in assisted reproductive technology treatment. [2023]The hormones used in fertility treatment come in various forms. Progesterone used for luteal phase support is often administered vaginally as either suppositories, tablets or gel. However, in Denmark the administration of progesterone as a subcutaneous injection has newly been introduced. The aim of the study was to explore patient attitudes towards and satisfaction with subcutaneous injection of progesterone versus vaginal administration of progesterone in Assisted Reproductive Technology (ART) treatments.