Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vaginal Compared to Intramuscular Progesterone for Frozen Embryo Transfer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254577
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Shady Grove Fertility Reproductive Science Center

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

Condition or disease Intervention/treatment Phase
Infertility Drug: Endometrin® plus Progesterone in Oil (PIO) Drug: Progesterone in Oil (PIO) Only Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2014
Actual Primary Completion Date : April 27, 2018
Actual Study Completion Date : April 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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 Name: Progesterone in Sesame Oil Injection




Primary Outcome Measures :
  1. Live Birth [ Time Frame: ~40 weeks post Frozen Embryo Transfer ]
    Live born infant at 23 weeks' estimated gestational age or greater.


Secondary Outcome Measures :
  1. Ongoing Implantation Rate [ Time Frame: 7-8 weeks after embryo transfer ]
    maximum # fetal heartbeats divided by total number of embryos transferred

  2. Implantation rate [ Time Frame: 5-6 weeks post embryo transfer ]
    Maximum number of gestational sacs, divided by total number of embryos transferred

  3. Biochemical pregnancy [ Time Frame: ~10 days following embryo transfer ]
    detection of beta hCG (pregnancy hormone) above 5 IU/L

  4. Clinical pregnancy [ Time Frame: 5-6 weeks following embryo transfer ]
    Presence of gestational sac(s) at 5-6 weeks post ET

  5. Serum progesterone level [ Time Frame: ~10 days following embryo transfer ]
    blood draw

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254577


Locations
Layout table for location information
United States, District of Columbia
Shady Grove Fertility Center
Washington, District of Columbia, United States, 20006
Shady Grove Fertility Center
Washington, District of Columbia, United States, 20016
United States, Maryland
Shady Grove Fertility Center
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
United States, Pennsylvania
Shady Grove Fertility
Camp Hill, Pennsylvania, United States, 17011
Shady Grove Fertility Center
Chesterbrook, Pennsylvania, United States, 19087
United States, Virginia
Shady Grove Fertility Center
Annandale, Virginia, United States, 22003
Shady Grove Fertility Center
Leesburg, Virginia, United States, 20176
Shady Grove Fertility Center
Woodbridge, Virginia, United States, 22192
Sponsors and Collaborators
Shady Grove Fertility Reproductive Science Center
Ferring Pharmaceuticals
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Shady Grove Fertility Reproductive Science Center
ClinicalTrials.gov Identifier: NCT02254577    
Other Study ID Numbers: 13-0028
SUSTAIN ( Other Identifier: ShadyGroveFRSC )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Keywords provided by Shady Grove Fertility Reproductive Science Center:
Infertility
Progesterone
ART
IVF
FET
FBT
Frozen Embryo Transfer
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs