Infertility Clinical Trial
— PRECiSEOfficial title:
Day 3 vs Day 5 Embryo Transfer for Patients With Low Embryo Numbers Going Through in Vitro Fertilization (PILOT STUDY)
Verified date | November 2023 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this small-scale pilot study (10 patients) is to test the study protocol for an RCT comparing IVF outcomes between day 3 and day 5 embryo transfer in patients with five or fewer embryos in a fresh embryo transfer in vitro fertilization (IVF) cycle. Information derived from this RCT would allow us to maximize the chances of success for these patients undergoing IVF.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 28, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility | Inclusion Criteria: - First autologous IVF cycle - Written, informed consent Exclusion Criteria: - Planned gestational carrier - Planned donor egg - Morbid obesity: BMI >40 - History of recurrent pregnancy loss (=2 spontaneous abortions) - Presence of uterine factor infertility - Treatment plan includes embryos cultured 'out of protocol' - Planned preimplantation genetic testing |
Country | Name | City | State |
---|---|---|---|
United States | Boston IVF | Waltham | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Boston IVF |
United States,
Gardner DK, Schoolcraft WB, Wagley L, Schlenker T, Stevens J, Hesla J. A prospective randomized trial of blastocyst culture and transfer in in-vitro fertilization. Hum Reprod. 1998 Dec;13(12):3434-40. doi: 10.1093/humrep/13.12.3434. — View Citation
Glujovsky D, Farquhar C, Quinteiro Retamar AM, Alvarez Sedo CR, Blake D. Cleavage stage versus blastocyst stage embryo transfer in assisted reproductive technology. Cochrane Database Syst Rev. 2016 Jun 30;(6):CD002118. doi: 10.1002/14651858.CD002118.pub5. — View Citation
Marek D, Langley M, Gardner DK, Confer N, Doody KM, Doody KJ. Introduction of blastocyst culture and transfer for all patients in an in vitro fertilization program. Fertil Steril. 1999 Dec;72(6):1035-40. doi: 10.1016/s0015-0282(99)00409-4. — View Citation
Papanikolaou EG, Camus M, Kolibianakis EM, Van Landuyt L, Van Steirteghem A, Devroey P. In vitro fertilization with single blastocyst-stage versus single cleavage-stage embryos. N Engl J Med. 2006 Mar 16;354(11):1139-46. doi: 10.1056/NEJMoa053524. — View Citation
Papanikolaou EG, D'haeseleer E, Verheyen G, Van de Velde H, Camus M, Van Steirteghem A, Devroey P, Tournaye H. Live birth rate is significantly higher after blastocyst transfer than after cleavage-stage embryo transfer when at least four embryos are available on day 3 of embryo culture. A randomized prospective study. Hum Reprod. 2005 Nov;20(11):3198-203. doi: 10.1093/humrep/dei217. Epub 2005 Jul 29. — View Citation
Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Blastocyst culture and transfer in clinical-assisted reproduction: a committee opinion. Fertil Steril. 2013 Mar 1;99(3):667-72. doi: 10.1016/j.fertnstert.2013.01.087. — View Citation
Tsirigotis M. Blastocyst stage transfer: pitfalls and benefits. Too soon to abandon current practice? Hum Reprod. 1998 Dec;13(12):3285-9. doi: 10.1093/humrep/13.12.3285. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | live birth | defined as delivery of a live born infant =22 weeks of gestation | 9 months | |
Secondary | Clinical pregnancy | defined by confirmation of a gestational sac on ultrasound | 14 days | |
Secondary | Ongoing pregnancy | defined by ultrasound confirmation of a gestational sac with at least one fetal pole with a fetal heartbeat | 9 months | |
Secondary | Multiple pregnancy | defined as twins or higher-order gestations | 9 months | |
Secondary | Time to pregnancy/live birth | 2 years |
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