Freeze All Strategy Versus Fresh Embryo Transfer After GnRH Analogue Trigger

NCT05362734 | Completed

• 1 other identifier: 999
• Study Type: observational
• Target: 1,396
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ovarian hyperstimulation syndrome (OHSS) is one of the most dangerous complications of assisted reproduction technology (ART), described in approximatively 3 to 10% of stimulation cycles although an underestimation of the real incidence has been suggested. The use in clinical practice of GnRH antagonist has made it possible to perform the trigger with GnRH analogues, with the advantage of considerably reducing the risk of OHSS.

Conditions

Ovarian Hyperstimulation Syndrome; Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• ongoing pregnancy rate

  number of viable pregnancies that had completed at least 12 weeks of gestation on the total number of ETs performed

  8 years

• delivery rate

  number of deliveries of one or more live births over the total performed ET

  8 years

Secondary Outcomes (3)

• Other pregnancy outcomes

  8 years

• Safety profile

  8 years

• the dropout rate

  8 years

Study Arms (2)

First fresh embryo transfer (group A)

The two groups analysed were defined according to the modality of first embryo transfer: cycles in which a fresh ET was performed at first, after a dual triggering or a rescue protocol (Group A) and cycles where a frozen-thawed ET was performed at first, after being chosen a freeze-all strategy (Group B).

Behavioral: obstetric outcomes after fresh versus cryopreserved embryo transfer

First cryopreserved embryo transfer (group B)

The two groups analysed were defined according to the modality of first embryo transfer: cycles in which a fresh ET was performed at first, after a dual triggering or a rescue protocol (Group A) and cycles where a frozen-thawed ET was performed at first, after being chosen a freeze-all strategy (Group B).

Behavioral: obstetric outcomes after fresh versus cryopreserved embryo transfer

Interventions

obstetric outcomes after fresh versus cryopreserved embryo transfer BEHAVIORAL

measure of ongoing pregnancy rate, delivery rate, abortion rate, ectopic pregnancy rate, multiple birth rate, ovarian hyperstimulation syndrome incidence, drop out rate

First cryopreserved embryo transfer (group B); First fresh embryo transfer (group A)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study database includes all Oocyte Retrievals (OR) performed between 01/01/2012 and 31/12/2020 at Humanitas Fertility Center after antagonist protocol stimulation and trigger with GnRH agonist.

You may qualify if:

• patients undergoing ART cycle with antagonist protocol stimulation and trigger with GnRH agonist
• patients are believed at risk of OHSS at time of trigger based on size and number of follicles developed (≥18 follicles with diameter 12 mm at induction).

You may not qualify if:

• hypogonadotropic hypogonadism
• other ART protocols
• any patient that underwent freeze-all strategy in order to perform pre-implantation genetic testing (PGT)
• oncological or deferring motherhood freezing procedures

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Related Publications (15)

• Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27.

  PMID: 25069504 BACKGROUND

• Humaidan P, Nelson SM, Devroey P, Coddington CC, Schwartz LB, Gordon K, Frattarelli JL, Tarlatzis BC, Fatemi HM, Lutjen P, Stegmann BJ. Ovarian hyperstimulation syndrome: review and new classification criteria for reporting in clinical trials. Hum Reprod. 2016 Sep;31(9):1997-2004. doi: 10.1093/humrep/dew149. Epub 2016 Jun 23.

  PMID: 27343272 BACKGROUND

• Levi-Setti PE, Di Segni N, Gargasole C, Ronchetti C, Cirillo F. Ovarian Hyperstimulation: Diagnosis, Prevention, and Management. Semin Reprod Med. 2021 Nov;39(5-06):170-179. doi: 10.1055/s-0041-1736492. Epub 2021 Oct 13.

  PMID: 34644798 BACKGROUND

• De Geyter C, Calhaz-Jorge C, Kupka MS, Wyns C, Mocanu E, Motrenko T, Scaravelli G, Smeenk J, Vidakovic S, Goossens V; European IVF-monitoring Consortium (EIM) for the European Society of Human Reproduction and Embryology (ESHRE). ART in Europe, 2015: results generated from European registries by ESHRE. Hum Reprod Open. 2020 Feb 24;2020(1):hoz038. doi: 10.1093/hropen/hoz038. eCollection 2020.

  PMID: 32123753 BACKGROUND

• Humaidan P, Kol S, Papanikolaou EG; Copenhagen GnRH Agonist Triggering Workshop Group. GnRH agonist for triggering of final oocyte maturation: time for a change of practice? Hum Reprod Update. 2011 Jul-Aug;17(4):510-24. doi: 10.1093/humupd/dmr008. Epub 2011 Mar 30.

  PMID: 21450755 BACKGROUND

• Humaidan P, Bredkjaer HE, Bungum L, Bungum M, Grondahl ML, Westergaard L, Andersen CY. GnRH agonist (buserelin) or hCG for ovulation induction in GnRH antagonist IVF/ICSI cycles: a prospective randomized study. Hum Reprod. 2005 May;20(5):1213-20. doi: 10.1093/humrep/deh765. Epub 2005 Mar 10.

  PMID: 15760966 BACKGROUND

• Lawrenz B, Coughlan C, Fatemi HM. Individualized luteal phase support. Curr Opin Obstet Gynecol. 2019 Jun;31(3):177-182. doi: 10.1097/GCO.0000000000000530.

  PMID: 30855289 BACKGROUND

• Abbara A, Islam R, Clarke SA, Jeffers L, Christopoulos G, Comninos AN, Salim R, Lavery SA, Vuong TNL, Humaidan P, Kelsey TW, Trew GH, Dhillo WS. Clinical parameters of ovarian hyperstimulation syndrome following different hormonal triggers of oocyte maturation in IVF treatment. Clin Endocrinol (Oxf). 2018 Jun;88(6):920-927. doi: 10.1111/cen.13569. Epub 2018 Mar 6.

  PMID: 29446481 BACKGROUND

• Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, Rienzi L, Sunde A, Schmidt L, Cooke ID, Simpson JL, van der Poel S. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017 Sep;108(3):393-406. doi: 10.1016/j.fertnstert.2017.06.005. Epub 2017 Jul 29.

  PMID: 28760517 BACKGROUND

• ESHRE Special Interest Group of Embryology and Alpha Scientists in Reproductive Medicine. Electronic address: coticchio.biogenesi@grupposandonato.it. The Vienna consensus: report of an expert meeting on the development of ART laboratory performance indicators. Reprod Biomed Online. 2017 Nov;35(5):494-510. doi: 10.1016/j.rbmo.2017.06.015. Epub 2017 Aug 4.

  PMID: 28784335 BACKGROUND

• ESHRE Clinic PI Working Group; Vlaisavljevic V, Apter S, Capalbo A, D'Angelo A, Gianaroli L, Griesinger G, Kolibianakis EM, Lainas G, Mardesic T, Motrenko T, Pelkonen S, Romualdi D, Vermeulen N, Tilleman K. The Maribor consensus: report of an expert meeting on the development of performance indicators for clinical practice in ART. Hum Reprod Open. 2021 Jul 3;2021(3):hoab022. doi: 10.1093/hropen/hoab022. eCollection 2021.

  PMID: 34250273 BACKGROUND

• Tomas C, Alsbjerg B, Martikainen H, Humaidan P. Pregnancy loss after frozen-embryo transfer--a comparison of three protocols. Fertil Steril. 2012 Nov;98(5):1165-9. doi: 10.1016/j.fertnstert.2012.07.1058. Epub 2012 Jul 27.

  PMID: 22840239 BACKGROUND

• ESHRE working group on Ectopic Pregnancy; Kirk E, Ankum P, Jakab A, Le Clef N, Ludwin A, Small R, Tellum T, Toyli M, Van den Bosch T, Jurkovic D. Terminology for describing normally sited and ectopic pregnancies on ultrasound: ESHRE recommendations for good practice. Hum Reprod Open. 2020 Dec 16;2020(4):hoaa055. doi: 10.1093/hropen/hoaa055. eCollection 2020.

  PMID: 33354626 BACKGROUND

• Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 191: Tubal Ectopic Pregnancy. Obstet Gynecol. 2018 Feb;131(2):e65-e77. doi: 10.1097/AOG.0000000000002464.

  PMID: 29232273 BACKGROUND

• Sunkara SK, Zheng W, D'Hooghe T, Longobardi S, Boivin J. Time as an outcome measure in fertility-related clinical studies: long-awaited. Hum Reprod. 2020 Aug 1;35(8):1732-1739. doi: 10.1093/humrep/deaa138.

  PMID: 32644107 BACKGROUND

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: January 1, 2012
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share