Vaginal Compared to Intramuscular Progesterone for Frozen Embryo Transfer

July 31, 2018 updated by: Shady Grove Fertility Reproductive Science Center

A Randomized, Three-armed, Non-Inferiority Study of Vaginal Progesterone (Endometrin®) Compared to Intramuscular Progesterone in Oil (PIO) in Infertile Subjects Undergoing Frozen Embryo Transfer (FET)

To determine whether the of vaginal progesterone replacement for frozen embryo transfer results in equivalent live birth rates to intramuscular injection progesterone replacement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this ongoing study is to look at whether Endometrin® (vaginal micronized progesterone tablets) supplemented by intramuscular injection of progesterone in oil (PIO) work as well as PIO alone for women undergoing transfer of frozen-thawed blastocyst(s). Another goal of the study is to determine whether patients prefer Endometrin or PIO. Endometrin® has been approved by the United States Food and Drug Administration, or FDA, "to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women." (FDA New Drug Approval Letter, Endometrin®, 2007). The use of Endometrin® (vaginal micronized progesterone tablets) in this study is investigational. An investigational use is one that is not approved by the U.S. Food and Drug Administration (FDA).

Approximately 1170 women between the ages of 18-48 who are having difficulty becoming pregnant and wish to undergo frozen embryo transfer will be asked to participate. The participants will be recruited from among patients of Shady Grove Fertility.

One-half of the participants who qualify and wish to take part in the ongoing study will be randomized (assigned by chance, like the flip of a coin) to receive Endometrin® and an intramuscular injection of PIO every third day. One-half will be randomized to receive an intramuscular injection of PIO every day. This study is a type of study called an "open label," assessor-blind study. This means that you and your doctor will know which treatment you are assigned and receive; however, the person analyzing the information obtained from the study will not know which patients received which study treatments.

Patients enrolling in the study will receive the medications for their frozen embryo transfer cycle free of charge.

Study Type

Interventional

Enrollment (Actual)

1139

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
        • Shady Grove Fertility Center
      • Washington, District of Columbia, United States, 20016
        • Shady Grove Fertility Center
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Shady Grove Fertility Center
      • Baltimore, Maryland, United States, 21202
        • Shady Grove Fertility Center
      • Bel Air, Maryland, United States, 21015
        • Shady Grove Fertility Center
      • Columbia, Maryland, United States, 21044
        • Shady Grove Fertility Center
      • Frederick, Maryland, United States, 21702
        • Shady Grove Fertility Center
      • Rockville, Maryland, United States, 20850
        • Shady Grove Fertility Center
      • Towson, Maryland, United States, 21204
        • Shady Grove Fertility Center
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Shady Grove Fertility
      • Chesterbrook, Pennsylvania, United States, 19087
        • Shady Grove Fertility Center
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Shady Grove Fertility Center
      • Leesburg, Virginia, United States, 20176
        • Shady Grove Fertility Center
      • Woodbridge, Virginia, United States, 22192
        • Shady Grove Fertility Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Signed informed consent
  2. Female age between 18 and 48 years
  3. Having available blastocyst(s) frozen by vitrification method at our center (Shady Grove Fertility).
  4. Standard eligibility criteria to undergo frozen blastocyst transfer at Shady Grove Fertility.

Exclusion Criteria:

  1. Requires fresh embryos or surrogate carrier
  2. Embryos from frozen oocytes and embryos frozen more than once
  3. Any embryo cryopreserved by slow freeze method and/or prior to blastocyst stage
  4. Presence of any clinically relevant systemic disease contraindicated for ART
  5. History of more than 3 failed cycles in previous ART attempts and/or more than 3 recurrent pregnancy losses after ET
  6. Surgical or medical condition or requirement for medication, which may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
  7. Subjects with a body mass index (BMI) of <18 or >38 kg/m2 at screening
  8. Current or recent substance abuse, including alcohol and tobacco. (Note: Subjects who stopped tobacco usage at least 3 months prior to screening visit will be allowed)
  9. Currently breast feeding, pregnant, or having (a) contraindication(s) to pregnancy
  10. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests
  11. Trophectoderm or blastomere biopsy of the blastocyst(s) to be transferred.
  12. Documented intolerance or allergy to any of the medications used, including the study medication
  13. Participation in any experimental drug study within 60 days prior to screening
  14. If a subject undergoes more than two frozen blastocyst transfers meeting study criteria, she will only be eligible to enroll in the study for two of these.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endometrin® plus Progesterone in Oil (PIO)
Subjects in all arms will undergo the standard monitoring appointments and therapies involved in a frozen embryo transfer cycle. Patients randomized to the Endometrin® plus PIO arm will take progesterone as 2 100mg tablets of Endometrin® inserted vaginally twice daily. In addition, on the first day of Endometrin® therapy, patients randomized to this arm will take a 50mg intramuscular injection (1mL) of PIO and will repeat this injection every third day. Patients in this arm will undergo Frozen Embryo Transfer on the fifth day of Endometrin® therapy.
Drug: Endometrin® plus Progesterone in Oil (PIO)
Other Names:
  • Vaginal Micronized Progesterone Tablet
  • Progesterone in Sesame Oil Injection
Active Comparator: Progesterone in Oil (PIO) Alone
Subjects in all arms will undergo the standard monitoring appointments and therapies involved in a frozen embryo transfer cycle. Patients randomized to the PIO Only arm will take progesterone as a daily 50mg intramuscular injection (1mL) of PIO and will undergo Frozen Embryo Transfer on the sixth day of taking this medication.
Drug: Progesterone in Oil (PIO) Only
Other Names:
  • Progesterone in Sesame Oil Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live Birth
Time Frame: ~40 weeks post Frozen Embryo Transfer
Live born infant at 23 weeks' estimated gestational age or greater.
~40 weeks post Frozen Embryo Transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing Implantation Rate
Time Frame: 7-8 weeks after embryo transfer
maximum # fetal heartbeats divided by total number of embryos transferred
7-8 weeks after embryo transfer
Implantation rate
Time Frame: 5-6 weeks post embryo transfer
Maximum number of gestational sacs, divided by total number of embryos transferred
5-6 weeks post embryo transfer
Biochemical pregnancy
Time Frame: ~10 days following embryo transfer
detection of beta hCG (pregnancy hormone) above 5 IU/L
~10 days following embryo transfer
Clinical pregnancy
Time Frame: 5-6 weeks following embryo transfer
Presence of gestational sac(s) at 5-6 weeks post ET
5-6 weeks following embryo transfer
Serum progesterone level
Time Frame: ~10 days following embryo transfer
blood draw
~10 days following embryo transfer
Patient satisfaction with Endometrin® vs. intramuscular progesterone in oil
Time Frame: between 0 and 10 days following embryo transfer
As assessed by brief, optional online survey
between 0 and 10 days following embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shady Grove Fertility Reproductive Science Center

Collaborators

Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

April 27, 2018

Study Completion (Actual)

April 27, 2018

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0028
  • SUSTAIN (ShadyGroveFRSC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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