NCT04549116

Brief 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 (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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for phase_3

Timeline
2mo left

Started Oct 2022

Typical duration for phase_3

Geographic Reach
1 country

22 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Oct 2022Jun 2026

First Submitted

Initial submission to the registry

August 31, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

October 12, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

August 31, 2020

Last Update Submit

January 23, 2026

Conditions

Infertility

Keywords

Frozen embryo transfer

Outcome Measures

Primary Outcomes (2)

  • Clinical pregnancy rate

    defined by the presence of an intrauterine fetal heart beat

    5 weeks post-embryo transfer

  • Ongoing pregnancy

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

    10 weeks post-embryo transfer

Secondary Outcomes (11)

  • Positive pregnancy rate

    10+/-2 days after embryo transfer.

  • Implantation rate

    6 weeks after embryo transfer,

  • Delivery rate

    2-4 weeks post expected delivery date.

  • Live birth rate

    2-4 weeks post expected delivery date.

  • Cycle cancellation rate (with reason)

    from treatment start until 10 weeks of pregnancy

  • +6 more secondary outcomes

Other Outcomes (1)

  • Progesterone Pharmacokinetic (PK) characterization

    4 days after treatment start.

Study Arms (2)

Investigational

EXPERIMENTAL

Progesterone-IBSA 25mg, twice daily (BID) subcutaneous (SC) injection every 12 hours and Crinone Placebo, once daily (QD) intravaginally.

Drug: Progesterone-IBSA Injectable SolutionDrug: Placebo Vaginal gel with applicator

Comparator

ACTIVE COMPARATOR

Crinone 8%, 90 mg, QD intravaginally and Progesterone-IBSA Placebo, BID SC Injection every 12 hours

Drug: Progesterone Vaginal Gel with ApplicatorDrug: Placebo injectable solution

Interventions

Progesterone-IBSA Injectable SolutionDRUG

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

Also known as: Prolutex
Investigational
Progesterone Vaginal Gel with ApplicatorDRUG

Crinone 8%, 90 mg, QD intravaginally

Also known as: Crinone
Comparator
Placebo Vaginal gel with applicatorDRUG

Vaginal gel Placebo, once daily (QD) intravaginally

Investigational
Placebo injectable solutionDRUG

Placebo injectable solution, BID SC Injection every 12 hours

Comparator

Eligibility Criteria

Age35 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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);
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

The Fertility Treatment Center, LLC

Tempe, Arizona, 85284, United States

Location

HRC Fertility

Encino, California, 91436, United States

Location

Kindbody

Los Angeles, California, 90067, United States

Location

San Diego Fertility

San Diego, California, 92130, United States

Location

Spring Fertility

San Francisco, California, 94109, United States

Location

Illume Fertility

Norwalk, Connecticut, 06851, United States

Location

Reproductive Associates of Delaware

Newark, Delaware, 19713, United States

Location

Women's Medical Research Group, LLC

Clearwater, Florida, 33759, United States

Location

IVF Florida Reproductive Associates

Margate, Florida, 33063, United States

Location

The IVF Center

Winter Park, Florida, 32792, United States

Location

InVia Fertility Specialists, PLLP

Hoffman Estates, Illinois, 60169, United States

Location

Johns Hopkins Fertility Center

Lutherville, Maryland, 21093, United States

Location

University Reproductive Associates, PC

Hasbrouck Heights, New Jersey, 07604, United States

Location

Reproductive Endocrinology Associates of Charlotte

Charlotte, North Carolina, 28207, United States

Location

Carolina Conceptions

Raleigh, North Carolina, 27607, United States

Location

Institute for Reproductive Health

Cincinnati, Ohio, 45209, United States

Location

Main Line Fertility

Bryn Mawr, Pennsylvania, 19010, United States

Location

Shady Grove Fertility

Chesterbrook, Pennsylvania, 19087, United States

Location

Care Fertility

Bedford, Texas, 76022, United States

Location

Aspire Houston Fertility Institute

Houston, Texas, 77063, United States

Location

Center of Reproductive Medicine, LLC., Shady Grove Fertility

Webster, Texas, 77598, United States

Location

Utah Fertility Center, PC

Pleasant Grove, Utah, 84062, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Crinone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind, double-dummy.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 16, 2020

Study Start

October 12, 2022

Primary Completion

January 20, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

US(22)