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 RateImplantation 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
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