Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.

NCT ID: NCT04549116

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-12
• Study Completion Date: 2026-06-30

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Investigational

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

Group Type: EXPERIMENTAL

Progesterone-IBSA Injectable Solution

Intervention Type: DRUG

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

Placebo Vaginal gel with applicator

Intervention Type: DRUG

Vaginal gel Placebo, once daily (QD) intravaginally

Comparator

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

Group Type: ACTIVE_COMPARATOR

Progesterone Vaginal Gel with Applicator

Intervention Type: DRUG

Crinone 8%, 90 mg, QD intravaginally

Placebo injectable solution

Intervention Type: DRUG

Placebo injectable solution, BID SC Injection every 12 hours

Interventions

Progesterone-IBSA Injectable Solution

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

Intervention Type: DRUG

Progesterone Vaginal Gel with Applicator

Crinone 8%, 90 mg, QD intravaginally

Intervention Type: DRUG

Placebo Vaginal gel with applicator

Vaginal gel Placebo, once daily (QD) intravaginally

Intervention Type: DRUG

Placebo injectable solution

Placebo injectable solution, BID SC Injection every 12 hours

Intervention Type: DRUG

Other Intervention Names

Prolutex; Crinone

Eligibility Criteria

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-

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IBSA Institut Biochimique SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fertility Treatment Center, LLC

Tempe, Arizona, United States

HRC Fertility

Encino, California, United States

Kindbody

Los Angeles, California, United States

San Diego Fertility

San Diego, California, United States

Spring Fertility

San Francisco, California, United States

Illume Fertility

Norwalk, Connecticut, United States

Reproductive Associates of Delaware

Newark, Delaware, United States

Women's Medical Research Group, LLC

Clearwater, Florida, United States

IVF Florida Reproductive Associates

Margate, Florida, United States

The IVF Center

Winter Park, Florida, United States

InVia Fertility Specialists, PLLP

Hoffman Estates, Illinois, United States

Johns Hopkins Fertility Center

Lutherville, Maryland, United States

University Reproductive Associates, PC

Hasbrouck Heights, New Jersey, United States

Reproductive Endocrinology Associates of Charlotte

Charlotte, North Carolina, United States

Carolina Conceptions

Raleigh, North Carolina, United States

Institute for Reproductive Health

Cincinnati, Ohio, United States

Main Line Fertility

Bryn Mawr, Pennsylvania, United States

Shady Grove Fertility

Chesterbrook, Pennsylvania, United States

Care Fertility

Bedford, Texas, United States

Aspire Houston Fertility Institute

Houston, Texas, United States

Center of Reproductive Medicine, LLC., Shady Grove Fertility

Webster, Texas, United States

Utah Fertility Center, PC

Pleasant Grove, Utah, United States

Countries

United States

Other Identifiers

20US-Prg03

Identifier Type: -

Identifier Source: org_study_id