Home › Trials › NCT04549116

Using Progesterone to Support Frozen Embryo Transfers in Women

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.

PHASE3 · IBSA Institut Biochimique SA · NCT04549116

This study is testing whether a new injectable progesterone can help women aged 35 to 42 have successful pregnancies after frozen embryo transfers compared to a vaginal gel treatment.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment680 (estimated)
Ages35 Years to 42 Years
SexFemale
SponsorIBSA Institut Biochimique SA (industry)
Drugs / interventionschemotherapy
Locations21 sites (Tempe, Arizona and 20 other locations)
Trial IDNCT04549116 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind clinical study aims to evaluate the safety and efficacy of Progesterone-IBSA in supporting the implantation of euploid blastocysts and early pregnancy in women aged 35 to 42 undergoing frozen embryo transfer. Participants will be randomly assigned to receive either the active Progesterone-IBSA injectable solution or Crinone 8% vaginal gel for luteal phase support. The study will compare outcomes between these two groups to determine the effectiveness of the treatments in facilitating successful pregnancies.

Who should consider this trial

Good fit: Ideal candidates are premenopausal women aged 35 to 42 with a history of infertility and at least one euploid frozen blastocyst available for transfer.

Not a fit: Patients with a BMI over 38 kg/m2 or those who have had more than three consecutive euploid blastocyst transfers without a live birth may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve pregnancy rates for women undergoing frozen embryo transfers.

How similar studies have performed: Other studies have shown promising results with similar approaches in supporting embryo implantation, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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-

Where this trial is running

Tempe, Arizona and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Infertility, Frozen embryo transfer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.