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

Luteal Phase Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05089383
• Other study ID #: ARETAIEION UNIVERSITY HOSPITAL
• Status: Recruiting
• Start date: September 14, 2021
• Est. completion date: December 2023

Study information

• Verified date: October 2021
• Source: University of Athens
• Contact: Vasiliki Dourou
• Phone: +306977706799
• Email: vdourou[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In ART (IVF/ICSI), most of the studies have shown a deficiency of progesterone during the luteal phase, especially due to the use of GnRH analogs. The lack of progesterone leads to abnormal endometrial development and consequently to desynchronization between the latter and the blastocyst implantation. Therefore, it is a standard of care to use progesterone for luteal phase support after embryo transfer and during the first trimester, in case of pregnancy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 698
• Est. completion date: December 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Luteal Phase

Intervention

Drug:
• Utrogestan
PROSPECTIVE STUDY

Locations

Country	Name	City	State
Greece	National and Kapodistrian University of Athens	Athens	Attica

Sponsors (2)

Lead Sponsor	Collaborator
University of Athens	Iaso Maternity Hospital, Athens, Greece

Country where clinical trial is conducted

Greece, 

References & Publications (7)

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. — View Citation

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. — View Citation

Pabuçcu E, Pabuçcu R, Gürgan 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. [Epub ahead of print] Review. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Hum Reprod. 2017 Oct 1;32(10):2152. — View Citation

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;(7):CD009154. doi: 10.1002/14651858.CD009154.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	The percentage of viable embryo after 20 weeks of gestation	9 months]
Primary	Abortion rate	Loss of pregnancy up to 20 weeks of gestation	20 weeks