Status:
COMPLETED
Vaginal Compared to Intramuscular Progesterone for Frozen Embryo Transfer
Lead Sponsor:
Shady Grove Fertility Reproductive Science Center
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
FEMALE
18-48 years
Phase:
PHASE4
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.
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 a...
Eligibility Criteria
Inclusion
- Signed informed consent
- Female age between 18 and 48 years
- Having available blastocyst(s) frozen by vitrification method at our center (Shady Grove Fertility).
- Standard eligibility criteria to undergo frozen blastocyst transfer at Shady Grove Fertility.
Exclusion
- Requires fresh embryos or surrogate carrier
- Embryos from frozen oocytes and embryos frozen more than once
- Any embryo cryopreserved by slow freeze method and/or prior to blastocyst stage
- Presence of any clinically relevant systemic disease contraindicated for ART
- History of more than 3 failed cycles in previous ART attempts and/or more than 3 recurrent pregnancy losses after ET
- Surgical or medical condition or requirement for medication, which may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
- Subjects with a body mass index (BMI) of \<18 or \>38 kg/m2 at screening
- 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)
- Currently breast feeding, pregnant, or having (a) contraindication(s) to pregnancy
- Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests
- Trophectoderm or blastomere biopsy of the blastocyst(s) to be transferred.
- Documented intolerance or allergy to any of the medications used, including the study medication
- Participation in any experimental drug study within 60 days prior to screening
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2018
Estimated Enrollment :
1139 Patients enrolled
Trial Details
Trial ID
NCT02254577
Start Date
October 1 2014
End Date
April 27 2018
Last Update
August 2 2018
Active Locations (14)
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1
Shady Grove Fertility Center
Washington D.C., District of Columbia, United States, 20006
2
Shady Grove Fertility Center
Washington D.C., District of Columbia, United States, 20016
3
Shady Grove Fertility Center
Annapolis, Maryland, United States, 21401
4
Shady Grove Fertility Center
Baltimore, Maryland, United States, 21202