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Needle or gel? new study tests better way to boost IVF success

NCT ID NCT04549116

Disease control Sponsor: IBSA Institut Biochimique SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests whether a progesterone shot under the skin works as well as a vaginal gel for supporting early pregnancy after a frozen embryo transfer. About 688 women aged 35 to 42 with infertility will take part. The goal is to see which method leads to more successful pregnancies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

688 people

The number who actually took part.

Started

Oct 2022

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 42 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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-

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Conditions

The condition(s) this trial relates to.

infertility disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infertility

Contacts and locations

Locations

  • Aspire Houston Fertility Institute

    Houston, Texas, 77063, United States

  • Care Fertility

    Bedford, Texas, 76022, United States

  • Carolina Conceptions

    Raleigh, North Carolina, 27607, United States

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

    Webster, Texas, 77598, United States

  • HRC Fertility

    Encino, California, 91436, United States

  • IVF Florida Reproductive Associates

    Margate, Florida, 33063, United States

  • Illume Fertility

    Norwalk, Connecticut, 06851, United States

  • InVia Fertility Specialists, PLLP

    Hoffman Estates, Illinois, 60169, United States

  • Institute for Reproductive Health

    Cincinnati, Ohio, 45209, United States

  • Johns Hopkins Fertility Center

    Lutherville, Maryland, 21093, United States

  • Kindbody

    Los Angeles, California, 90067, United States

  • Main Line Fertility

    Bryn Mawr, Pennsylvania, 19010, United States

  • Reproductive Associates of Delaware

    Newark, Delaware, 19713, United States

  • Reproductive Endocrinology Associates of Charlotte

    Charlotte, North Carolina, 28207, United States

  • San Diego Fertility

    San Diego, California, 92130, United States

  • Shady Grove Fertility

    Rockville, Maryland, 20850, United States

  • Shady Grove Fertility

    Chesterbrook, Pennsylvania, 19087, United States

  • Spring Fertility

    San Francisco, California, 94109, United States

  • The Fertility Treatment Center, LLC

    Tempe, Arizona, 85284, United States

  • The IVF Center

    Winter Park, Florida, 32792, United States

  • University Reproductive Associates, PC

    Hasbrouck Heights, New Jersey, 07604, United States

  • University of Cincinnati Physicians Company

    Cincinnati, Ohio, 45209, United States

  • Utah Fertility Center, PC

    Pleasant Grove, Utah, 84062, United States

  • Women's Medical Research Group, LLC

    Clearwater, Florida, 33759, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.