Infertility Clinical Trial
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)
Verified date | July 2018 |
Source | Shady Grove Fertility Reproductive Science Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine whether the of vaginal progesterone replacement for frozen embryo transfer results in equivalent live birth rates to intramuscular injection progesterone replacement.
Status | Completed |
Enrollment | 1139 |
Est. completion date | April 27, 2018 |
Est. primary completion date | April 27, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Shady Grove Fertility Center | Annandale | Virginia |
United States | Shady Grove Fertility Center | Annapolis | Maryland |
United States | Shady Grove Fertility Center | Baltimore | Maryland |
United States | Shady Grove Fertility Center | Bel Air | Maryland |
United States | Shady Grove Fertility | Camp Hill | Pennsylvania |
United States | Shady Grove Fertility Center | Chesterbrook | Pennsylvania |
United States | Shady Grove Fertility Center | Columbia | Maryland |
United States | Shady Grove Fertility Center | Frederick | Maryland |
United States | Shady Grove Fertility Center | Leesburg | Virginia |
United States | Shady Grove Fertility Center | Rockville | Maryland |
United States | Shady Grove Fertility Center | Towson | Maryland |
United States | Shady Grove Fertility Center | Washington | District of Columbia |
United States | Shady Grove Fertility Center | Washington | District of Columbia |
United States | Shady Grove Fertility Center | Woodbridge | Virginia |
Lead Sponsor | Collaborator |
---|---|
Shady Grove Fertility Reproductive Science Center | Ferring Pharmaceuticals |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Live Birth | Live born infant at 23 weeks' estimated gestational age or greater. | ~40 weeks post Frozen Embryo Transfer | |
Secondary | Ongoing Implantation Rate | maximum # fetal heartbeats divided by total number of embryos transferred | 7-8 weeks after embryo transfer | |
Secondary | Implantation rate | Maximum number of gestational sacs, divided by total number of embryos transferred | 5-6 weeks post embryo transfer | |
Secondary | Biochemical pregnancy | detection of beta hCG (pregnancy hormone) above 5 IU/L | ~10 days following embryo transfer | |
Secondary | Clinical pregnancy | Presence of gestational sac(s) at 5-6 weeks post ET | 5-6 weeks following embryo transfer | |
Secondary | Serum progesterone level | blood draw | ~10 days following embryo transfer | |
Secondary | Patient satisfaction with Endometrin® vs. intramuscular progesterone in oil | As assessed by brief, optional online survey | between 0 and 10 days following embryo transfer |
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