AzTrials
AzTrials

InfertilityPhase 3PROGRESSNCT04549116

Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.

A Phase 3 study testing Progesterone-IBSA Injectable Solution and Progesterone Vaginal Gel with Applicator in people with Infertility, run by IBSA Institut Biochimique SA at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 35 to 42 years, women only
Conditions the study is for
Infertility
What is being tested?
Progesterone-IBSA Injectable Solution and Progesterone Vaginal Gel with Applicator
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
688 participants
Where
24 sitesUnited States
Study dates
12 Oct 2022to 25 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 42 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
Show all 11Show fewer
  • 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.

Who cannot join

  • 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;
Show all 26Show fewer
  • 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-

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Care Fertility

    Bedford, Texas, 76022

  • Main Line Fertility

    Bryn Mawr, Pennsylvania, 19010

  • Reproductive Endocrinology Associates of Charlotte

    Charlotte, North Carolina, 28207

  • Shady Grove Fertility

    Chesterbrook, Pennsylvania, 19087

  • Institute for Reproductive Health

    Cincinnati, Ohio, 45209

  • University of Cincinnati Physicians Company

    Cincinnati, Ohio, 45209

  • Women's Medical Research Group, LLC

    Clearwater, Florida, 33759

  • HRC Fertility

    Encino, California, 91436

  • University Reproductive Associates, PC

    Hasbrouck Heights, New Jersey, 07604

  • InVia Fertility Specialists, PLLP

    Hoffman Estates, Illinois, 60169

  • Aspire Houston Fertility Institute

    Houston, Texas, 77063

  • Kindbody

    Los Angeles, California, 90067

  • Johns Hopkins Fertility Center

    Lutherville, Maryland, 21093

  • IVF Florida Reproductive Associates

    Margate, Florida, 33063

  • Reproductive Associates of Delaware

    Newark, Delaware, 19713

  • Illume Fertility

    Norwalk, Connecticut, 06851

  • Utah Fertility Center, PC

    Pleasant Grove, Utah, 84062

  • Carolina Conceptions

    Raleigh, North Carolina, 27607

  • Shady Grove Fertility

    Rockville, Maryland, 20850

  • San Diego Fertility

    San Diego, California, 92130

  • Spring Fertility

    San Francisco, California, 94109

  • The Fertility Treatment Center, LLC

    Tempe, Arizona, 85284

  • Center of Reproductive Medicine, LLC., Shady Grove Fertility

    Webster, Texas, 77598

  • The IVF Center

    Winter Park, Florida, 32792

Other trials in United States

About this study

Official title: 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.

Conditions
Infertility
Being tested
Progesterone-IBSA Injectable Solution, Progesterone Vaginal Gel with Applicator, Placebo Vaginal gel with applicator, Placebo injectable solution
Keywords
Frozen embryo transfer
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progesterone-IBSA Injectable SolutionDrug

    Also called Prolutex

    Progesterone-IBSA 25mg, twice daily (BID) SC Injection every 12 hours

  • Progesterone Vaginal Gel with ApplicatorDrug

    Also called Crinone

    Crinone 8%, 90 mg, QD intravaginally

  • Placebo Vaginal gel with applicatorDrug

    Vaginal gel Placebo, once daily (QD) intravaginally

  • Placebo injectable solutionDrug

    Placebo injectable solution, BID SC Injection every 12 hours

Study groups in NCT04549116
Study groupRoleWhat they receive
InvestigationalExperimentalProgesterone-IBSA 25mg, twice daily (BID) subcutaneous (SC) injection every 12 hours and Crinone Placebo, once daily (QD) intravaginally.
Receives: Drug: Progesterone-IBSA Injectable Solution; Drug: Placebo Vaginal gel with applicator
ComparatorActive comparatorCrinone 8%, 90 mg, QD intravaginally and Progesterone-IBSA Placebo, BID SC Injection every 12 hours
Receives: Drug: Progesterone Vaginal Gel with Applicator; Drug: Placebo injectable solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical pregnancy rate

    defined by the presence of an intrauterine fetal heart beat

    Measured: 5 weeks post-embryo transfer

  2. Ongoing pregnancy

    defined by the presence of an ongoing intrauterine pregnancy with fetal heart beat

    Measured: 10 weeks post-embryo transfer

Secondary outcomes (11)

  1. Positive pregnancy rate

    positive serum β-human chorionic gonadotropin (hCG) test rate

    Measured: 10+/-2 days after embryo transfer.

  2. Implantation rate

    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 (%)

    Measured: 6 weeks after embryo transfer,

  3. Delivery rate

    defined as the number of deliveries with at least one live birth or stillbirth (%)

    Measured: 2-4 weeks post expected delivery date.

  4. Live birth rate

    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

    Measured: 2-4 weeks post expected delivery date.

  5. Cycle cancellation rate (with reason)

    defined as number of subjects dropping form the study at any time.

    Measured: from treatment start until 10 weeks of pregnancy

  6. Adverse Events related to the mother

    frequency and severity of adverse events related to the mother.

    Measured: from Informed consent signature until 2-4 week after delivery.

  7. Local tolerability

    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).

    Measured: from the 4th day of treatment administration until 10 weeks post embryo transfer.

  8. Early Miscarriage rate

    defined as a spontaneous loss of an intra-uterine pregnancy

    Measured: from 5 weeks post embryo transfer until the 12th week of pregnancy.

  9. Late miscarriage rate

    defined as a spontaneous loss of an intra-uterine pregnancy

    Measured: after the 12th week of pregnancy until delivery.

  10. Ectopic pregnancy rate

    defined as a pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology.

    Measured: from 5 weeks post embryo transfer until the 12th week of pregnancy.

  11. Adverse events related to the newborn.

    frequency and severity of adverse events related to the newborn.

    Measured: 2-4 weeks after expected delivery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start12 Oct 2022
  3. Primary completion20 Jan 2026
  4. Study completion25 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
688 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04549116
Sponsor's protocol ID
20US-Prg03
Acronym
PROGRESS
Status last verified
Aug 2026
First submitted
31 Aug 2020
Last updated
27 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Progesterone-IBSA Injectable Solution and Progesterone Vaginal Gel with Applicator in people with Infertility, run by IBSA Institut Biochimique SA at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical pregnancy rate (time frame: 5 weeks post-embryo transfer). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04549116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in