Vaginal Versus Combined Use of Progesterone in Fresh IVF/ICSI Cycles

NCT05089383 | Unknown FDA Drug

• 1 other identifier: ARETAIEION UNIVERSITY HOSPITAL
• Study Type: observational
• Target: 698
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: the combined use of progesterone administration for luteal phase support is superior to the single route of progesterone administration in terms of pregnancy outcome parameters in women undergoing fresh IVF/ICSI cycles.

Conditions

Luteal Phase

Keywords

IVF; PROGESTERONE

Outcome Measures

Primary Outcomes (2)

• Live birth rate

  The percentage of viable embryo after 20 weeks of gestation

  9 months]

• Abortion rate

  Loss of pregnancy up to 20 weeks of gestation

  20 weeks

Study Arms (2)

combined progesterone group

patients will receive vaginal plus subcutaneous or per os progesterone

Drug: Utrogestan

Vaginal progesterone group

patients will receive vaginal progesterone

Drug: Utrogestan

Interventions

Utrogestan DRUG

PROSPECTIVE STUDY

Also known as: PROLUTEX,VASCLOR

Vaginal progesterone group; combined progesterone group

Eligibility Criteria

• Age: 22 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Infertile couples with an indication for IVF/ICSI (both Units).

You may qualify if:

• Patients with a documented history of infertility, aged 22-40, undergoing fresh embryo transfer after IVF/ICSI, under informed consent.
• 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.

You may not qualify if:

• Endocrine or metabolic disorders, e.g., PCO (S), pathology of the uterus and/or endometrium, basal FSH levels\> 15 IU / ml, major surgery in the ovaries (removal), and age \<22 years and \> 40 years old.
• Active pelvic inflammatory disease
• IVF/ICSI with donor eggs
• Previous participation in this trial

Sponsors & Collaborators

• University of Athens: lead
• Iaso Maternity Hospital, Athens, Greece: collaborator

Study Sites (1)

National and Kapodistrian University of Athens

Athens, Attica, 11528, Greece

RECRUITING

Related Publications (7)

• 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.

  PMID: 26148507 BACKGROUND

• 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.

  PMID: 18406835 BACKGROUND

• 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.

  PMID: 32585391 BACKGROUND

• 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.

  PMID: 28333318 BACKGROUND

• 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.

  PMID: 25100106 BACKGROUND

• 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.

  PMID: 31032676 BACKGROUND

• 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.

  PMID: 30304457 BACKGROUND

MeSH Terms

Interventions

Utrogestan

Study Officials

• Nikolaos Vlachos

  National and Kapodistrian University of Athens

  STUDY DIRECTOR

Central Study Contacts

Vasiliki Dourou

CONTACT

+306977706799; vdourou@gmail.com

Nikolaos Vlachos

CONTACT

nfvlahos@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics, Gynecology and Assisted Reproduction

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: October 22, 2021
• Study Start: September 14, 2021
• Primary Completion: February 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

GR (1)