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Vaginal Compared to Intramuscular Progesterone for Frozen Embryo Transfer

Information source: Shady Grove Fertility Reproductive Science Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Endometrin® Only (Drug); Endometrin® plus Progesterone in Oil (PIO) (Drug); Progesterone in Oil (PIO) Only (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Shady Grove Fertility Reproductive Science Center

Overall contact:
Quiana Selby, B.S., Phone: 1-855-226-5537, Email: quiana.selby@integramed.com

Summary

Use of vaginal progesterone replacement for frozen embryo transfer results in equivalent live birth rates to intramuscular injection progesterone replacement.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Live Birth

Secondary outcome:

Ongoing Implantation Rate

Implantation rate

Biochemical pregnancy

Clinical pregnancy

Serum progesterone level

Patient satisfaction with Endometrin® vs. intramuscular progesterone in oil

Detailed description: The purpose of this study is to look at whether Endometrin® (vaginal micronized progesterone tablets) and/or Endometrin® 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-third of the participants who qualify and wish to take part in the study will be randomized (assigned by chance, like the flip of a coin) to receive Endometrin® alone. One-third will be randomized to receive Endometrin® and an intramuscular injection of PIO every third day. One-third 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.

Eligibility

Minimum age: 18 Years. Maximum age: 48 Years. Gender(s): Female.

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.

Locations and Contacts

Quiana Selby, B.S., Phone: 1-855-226-5537, Email: quiana.selby@integramed.com

Shady Grove Fertility Center, Washington, District of Columbia 20006, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Joseph Doyle, MD, Principal Investigator

Shady Grove Fertility Center, Washington, District of Columbia 20016, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Joseph Doyle, MD, Principal Investigator

Shady Grove Fertility Center, Annapolis, Maryland 21401, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Jeffrey McKeeby, MD, Principal Investigator

Shady Grove Fertility Center, Baltimore, Maryland 21202, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Stephanie Beall, MD, PhD, Principal Investigator

Shady Grove Fertility Center, Bel Air, Maryland 21015, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Jeffrey McKeeby, MD, Principal Investigator

Shady Grove Fertility Center, Columbia, Maryland 21044, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Stephanie Beall, MD, PhD, Principal Investigator

Shady Grove Fertility Center, Frederick, Maryland 21702, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Jason Bromer, MD, Principal Investigator

Shady Grove Fertility Center, Rockville, Maryland 20850, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Joseph Doyle, MD, Principal Investigator

Shady Grove Fertility Center, Towson, Maryland 21204, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Stephanie Beall, MD, PhD, Principal Investigator

Shady Grove Fertility Center, Chesterbrook, Pennsylvania 19087, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Isaac Sasson, MD, PhD, Principal Investigator

Shady Grove Fertility Center, Annandale, Virginia 22003, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Eric Levens, MD, Principal Investigator

Shady Grove Fertility Center, Leesburg, Virginia 20176, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Eric Levens, MD, Principal Investigator

Shady Grove Fertility Center, Woodbridge, Virginia 22192, United States; Not yet recruiting
Quiana Selby, Phone: 855-226-5537
Eric Levens, MD, Principal Investigator

Additional Information

Related publications:

Shapiro DB, Pappadakis JA, Ellsworth NM, Hait HI, Nagy ZP. Progesterone replacement with vaginal gel versus i.m. injection: cycle and pregnancy outcomes in IVF patients receiving vitrified blastocysts. Hum Reprod. 2014 Aug;29(8):1706-11. doi: 10.1093/humrep/deu121. Epub 2014 May 20.

Feinberg EC, Beltsos AN, Nicolaou E, Marut EL, Uhler ML. Endometrin as luteal phase support in assisted reproduction. Fertil Steril. 2013 Jan;99(1):174-8. doi: 10.1016/j.fertnstert.2012.09.019. Epub 2012 Nov 6.

Paulson RJ, Collins MG, Yankov VI. Progesterone pharmacokinetics and pharmacodynamics with 3 dosages and 2 regimens of an effervescent micronized progesterone vaginal insert. J Clin Endocrinol Metab. 2014 Nov;99(11):4241-9. doi: 10.1210/jc.2013-3937. Epub 2014 Feb 25.

Starting date: October 2014
Last updated: October 1, 2014

Page last updated: August 23, 2015

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