Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (PROGRESS)

June 3, 2026 updated by: IBSA Institut Biochimique SA

A Multicenter, Randomized, Controlled, Double-blind, Double-dummy Study to Evaluate the Safety and Efficacy of Subcutaneous Progesterone Compared to Vaginal Progesterone for Luteal Phase Supplementation in Modified Natural Frozen Euploid Blastocyst Transfer.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
688

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: R&D Scientific Affairs
  • Phone Number: +41 58 360 10 00
  • Email: sd@ibsa.ch

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85284
        • The Fertility Treatment Center, LLC
    • California
      • Encino, California, United States, 91436
        • HRC Fertility
      • Los Angeles, California, United States, 90067
        • Kindbody
      • San Diego, California, United States, 92130
        • San Diego Fertility
      • San Francisco, California, United States, 94109
        • Spring Fertility
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Illume Fertility
    • Delaware
      • Newark, Delaware, United States, 19713
        • Reproductive Associates of Delaware
    • Florida
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group, LLC
      • Margate, Florida, United States, 33063
        • IVF Florida Reproductive Associates
      • Winter Park, Florida, United States, 32792
        • The IVF Center
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • InVia Fertility Specialists, PLLP
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins Fertility Center
      • Rockville, Maryland, United States, 20850
        • Shady Grove Fertility
    • New Jersey
      • Hasbrouck Heights, New Jersey, United States, 07604
        • University Reproductive Associates, PC
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Reproductive Endocrinology Associates of Charlotte
      • Raleigh, North Carolina, United States, 27607
        • Carolina Conceptions
    • Ohio
      • Cincinnati, Ohio, United States, 45209
        • Institute for Reproductive Health
      • Cincinnati, Ohio, United States, 45209
        • University of Cincinnati Physicians Company
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Main Line Fertility
      • Chesterbrook, Pennsylvania, United States, 19087
        • Shady Grove Fertility
    • Texas
      • Bedford, Texas, United States, 76022
        • Care Fertility
      • Houston, Texas, United States, 77063
        • Aspire Houston Fertility Institute
      • Webster, Texas, United States, 77598
        • Center of Reproductive Medicine, LLC., Shady Grove Fertility
    • Utah
      • Pleasant Grove, Utah, United States, 84062
        • Utah Fertility Center, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

31 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • subject has given written informed consent;
  • 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]);
  • Valid indication for IVF treatment (i.e. history of infertility according to ASRM definition, single women or same-sex couples);
  • Consistent, regular spontaneous ovulatory menstrual cycle with normal length (24-38 days included);
  • Body mass index (BMI) < 38 kg/m2;
  • Subject with at least one euploid frozen blastocyst from a previous IVF treatment cycle;
  • Less than 3 previous consecutive euploid blastocyst transfers without a life birth;
  • Baseline Follicle Stimulating Hormone (FSH) < 15 mIU/mL, and Anti Muellerian Hormone (AMH) >0.7 ng/mL (within 6 months from screening for subjects requiring a stimulation cycle to obtain a euploid embryo); and Estradiol (E2) < 90 pg/mL and Progesterone (P4)< 1.5 ng/mL at Visit 1 (for all subjects);
  • Semen used during IVF(for subjects requiring a stimulation cycle to obtain a euploid embryo) was produced by ejaculation (not surgically derived sperm) from either the partner or from a sperm donor. Donor must be 18-40 years of age at the time of collection and compliant with 21 Code of Regulations (CFR) section 1271 Subpart C;
  • Hysterosalpingography, hysteroscopy, 3D ultrasound or sonohysterogram documenting a normal uterine cavity within the last year;
  • Normal cervical cytology/High Risk human papillomavirus (HPV) testing per American College of Obstetricians and Gynecologists guidelines.

Exclusion Criteria:

  • Oligo or anovulation (spontaneous menses > 39 days apart);
  • Breastfeeding or Pregnancy;
  • Contraindication to pregnancy (i.e. an active, uncontrolled clinically significant medical condition or abnormality of the sexual organs determined by the provider);
  • Known family history of major congenital anomalies;
  • Moderate to severe current endometriosis (stage 3 or 4);
  • Presence of a unilateral or bilateral hydrosalpinx that communicates with the uterus, that has not been ligated prior to treatment;
  • Recurrent pregnancy loss (RPL) as defined by the American Society of Reproductive Medicine (ASRM) as two or more consecutive failed clinical pregnancies;
  • Presence of a submucosal or intramural fibroid > 4 cm which distorts the uterine cavity or are > 5 cm in diameter;
  • Untreated uterine pathology that could impair embryo implantation (i.e. scarring/Asherman's syndrome or intra uterine polyps > 1 cm in size);
  • Type 1 or 2 diabetes mellitus based on American Diabetes Association (ADA) criteria3;
  • Uncontrolled adrenal or thyroid dysfunction;
  • History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product;
  • Subjects with hepatic impairment (liver function tests > 2x upper limit of normal);
  • Subjects with renal impairment (estimated creatinine clearance <60 mL/min/1.73 m2);
  • History of an active or treated autoimmune disease (i.e. systemic lupus erythematosus);
  • History of arterial disease (i.e. Prior or active thrombophlebitis, thromboembolic disorder or known thrombophilia);
  • Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
  • High grade cervical dysplasia;
  • Undiagnosed vaginal bleeding (i.e. at the time of screening);
  • Use of donor eggs or plans to use a gestational carrier;
  • Use of endometrial receptivity array (ERA) test to postpone or anticipate the embryo transfer (ET) day;
  • Use of epididymal, testicular , electro-ejaculated or chemotherapy exposed sperm;
  • Known allergy to progesterone preparations or their excipients;
  • Current dependence on alcohol, tobacco (must not be smoking/using tobacco x 2 months before the study) or drugs or psychotropic medications labeled as Pregnancy Categories D and X;
  • Use of concomitant medications within 1 month previous the start of the FET cycle preparation up to gestational week 12 that might interfere with the study evaluation (use of insulin sensitizing agents, vaginal medications/preparations, any drugs for luteal support other than those specified in the protocol, aspirin, any hormonal treatment, with the exception of levothyroxine);
  • Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Investigational
Progesterone-IBSA 25mg, twice daily (BID) subcutaneous (SC) injection every 12 hours and Crinone Placebo, once daily (QD) intravaginally.
Drug: Progesterone-IBSA Injectable Solution
Progesterone-IBSA 25mg, twice daily (BID) SC Injection every 12 hours
Other Names:
  • Prolutex
Drug: Placebo Vaginal gel with applicator
Vaginal gel Placebo, once daily (QD) intravaginally
Active Comparator: Comparator
Crinone 8%, 90 mg, QD intravaginally and Progesterone-IBSA Placebo, BID SC Injection every 12 hours
Drug: Progesterone Vaginal Gel with Applicator
Crinone 8%, 90 mg, QD intravaginally
Other Names:
  • Crinone
Drug: Placebo injectable solution
Placebo injectable solution, BID SC Injection every 12 hours

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 5 weeks post-embryo transfer
defined by the presence of an intrauterine fetal heart beat
5 weeks post-embryo transfer
Ongoing pregnancy
Time Frame: 10 weeks post-embryo transfer
defined by the presence of an ongoing intrauterine pregnancy with fetal heart beat
10 weeks post-embryo transfer

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positive pregnancy rate
Time Frame: 10+/-2 days after embryo transfer.
positive serum β-human chorionic gonadotropin (hCG) test rate
10+/-2 days after embryo transfer.
Implantation rate
Time Frame: 6 weeks after embryo transfer,
defined by the number of gestational sacs observed at Visit 6 by means of a transvaginal ultrasound (TVUS), divided by the number of blastocysts transferred (%)
6 weeks after embryo transfer,
Delivery rate
Time Frame: 2-4 weeks post expected delivery date.
defined as the number of deliveries with at least one live birth or stillbirth (%)
2-4 weeks post expected delivery date.
Live birth rate
Time Frame: 2-4 weeks post expected delivery date.
defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life
2-4 weeks post expected delivery date.
Cycle cancellation rate (with reason)
Time Frame: from treatment start until 10 weeks of pregnancy
defined as number of subjects dropping form the study at any time.
from treatment start until 10 weeks of pregnancy
Adverse Events related to the mother
Time Frame: from Informed consent signature until 2-4 week after delivery.
frequency and severity of adverse events related to the mother.
from Informed consent signature until 2-4 week after delivery.
Local tolerability
Time Frame: from the 4th day of treatment administration until 10 weeks post embryo transfer.
At each visit, the subject will be queried about the presence of local reactions at administration site (pain, redness, swelling and itching at injection site and pain, irritation, swelling and leakage in the genital area). Events will be described in term of nature, severity (mild, moderate, severe, or very severe) and duration (persisted for up to 1 hour, persisted for more than 1 up to 4 hours, persisted for more than 4 up to 12 hours, persisted for more than 12 hours).
from the 4th day of treatment administration until 10 weeks post embryo transfer.
Early Miscarriage rate
Time Frame: from 5 weeks post embryo transfer until the 12th week of pregnancy.
defined as a spontaneous loss of an intra-uterine pregnancy
from 5 weeks post embryo transfer until the 12th week of pregnancy.
Late miscarriage rate
Time Frame: after the 12th week of pregnancy until delivery.
defined as a spontaneous loss of an intra-uterine pregnancy
after the 12th week of pregnancy until delivery.
Ectopic pregnancy rate
Time Frame: from 5 weeks post embryo transfer until the 12th week of pregnancy.
defined as a pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology.
from 5 weeks post embryo transfer until the 12th week of pregnancy.
Adverse events related to the newborn.
Time Frame: 2-4 weeks after expected delivery.
frequency and severity of adverse events related to the newborn.
2-4 weeks after expected delivery.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progesterone Pharmacokinetic (PK) characterization
Time Frame: 4 days after treatment start.
Blood sampling to assess Progesterone levels will be collected in order to characterize the PK profile at steady state in the target population
4 days after treatment start.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IBSA Institut Biochimique SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20US-Prg03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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