Vaginal Versus Combined Use of Progesterone in Fresh IVF/ICSI Cycles
NCT ID: NCT05089383
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
698 participants
OBSERVATIONAL
2021-09-14
2023-12-31
Brief Summary
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Detailed Description
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According to ESHRE guidelines, either of vaginal, oral, subcutaneous or intramuscular route is advisable.
But, until now, there is no robust evidence on the effect on pregnancy outcome of the combined route of progesterone administration compared to the standard of care (single route).
The aim of this study is to compare the effectiveness of the combined route of progesterone administration to the single route.
The study is a prospective cohort study. Participants will receive either standard treatment with single route (vaginal) progesterone administration according to the ESHRE guidelines, or combination of more than one routes of administration, that is vaginal plus oral or subcutaneous progesterone, starting afterthe fresh embryo transfer until 12 weeks of gestation or a negative pregnancy test.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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combined progesterone group
patients will receive vaginal plus subcutaneous or per os progesterone
Utrogestan
PROSPECTIVE STUDY
Vaginal progesterone group
patients will receive vaginal progesterone
Utrogestan
PROSPECTIVE STUDY
Interventions
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Utrogestan
PROSPECTIVE STUDY
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Physiological menstrual cycles (24-35 days), normal endocrine function (FSH ≤ 15 IU / ml), transvaginal ultrasound without pathological findings, free personal medical history, indication for IVF/ICSI.
Exclusion Criteria
* Active pelvic inflammatory disease
* IVF/ICSI with donor eggs
* Previous participation in this trial
22 Years
40 Years
FEMALE
Yes
Sponsors
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Iaso Maternity Hospital, Athens, Greece
OTHER
University of Athens
OTHER
Responsible Party
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Nikos Vlahos
Professor of Obstetrics, Gynecology and Assisted Reproduction
Principal Investigators
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Nikolaos Vlachos
Role: STUDY_DIRECTOR
National and Kapodistrian University of Athens
Locations
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National and Kapodistrian University of Athens
Athens, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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References
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van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2015 Jul 7;2015(7):CD009154. doi: 10.1002/14651858.CD009154.pub3.
Practice Committee of the American Society for Reproductive Medicine. Progesterone supplementation during the luteal phase and in early pregnancy in the treatment of infertility: an educational bulletin. Fertil Steril. 2008 Apr;89(4):789-92. doi: 10.1016/j.fertnstert.2008.02.012.
Pabuccu E, Pabuccu R, Gurgan T, Tavmergen E. Luteal phase support in fresh and frozen embryo transfer cycles. J Gynecol Obstet Hum Reprod. 2020 Jun 22:101838. doi: 10.1016/j.jogoh.2020.101838. Online ahead of print.
Tournaye H, Sukhikh GT, Kahler E, Griesinger G. A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum Reprod. 2017 May 1;32(5):1019-1027. doi: 10.1093/humrep/dex023.
Baker VL, Jones CA, Doody K, Foulk R, Yee B, Adamson GD, Cometti B, DeVane G, Hubert G, Trevisan S, Hoehler F, Jones C, Soules M. A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization. Hum Reprod. 2014 Oct 10;29(10):2212-20. doi: 10.1093/humrep/deu194. Epub 2014 Aug 6.
Tomic V, Kasum M, Vucic K. The role of luteal support during IVF: a qualitative systematic review. Gynecol Endocrinol. 2019 Oct;35(10):829-834. doi: 10.1080/09513590.2019.1603288. Epub 2019 Apr 29.
Griesinger G, Blockeel C, Sukhikh GT, Patki A, Dhorepatil B, Yang DZ, Chen ZJ, Kahler E, Pexman-Fieth C, Tournaye H. Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial. Hum Reprod. 2018 Dec 1;33(12):2212-2221. doi: 10.1093/humrep/dey306.
Other Identifiers
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ARETAIEION UNIVERSITY HOSPITAL
Identifier Type: -
Identifier Source: org_study_id