RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER

NCT03837223 | Completed

• 1 other identifier: trigger
• Study Type: observational
• Target: 271
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ovarian Hyperstimulation Syndrome (OHSS) is one of the most dangerous complications of Assisted Reproductive Technologies (ART) cycles. The use in clinical practice of the GnRH antagonist has made it possible to perform the trigger with GnRH analogues reducing the risk of OHSS. The trigger with analogue increases the Abortion Rate (AR) and reduces the Ongoing Pregnancy Rate (OPR), because the luteal phase in these cycles is particularly deficient. To reduce this occurrence several studies have focused on the importance of support of the luteal phase. The aims of study is to evaluate OPR and AR in patients at intermediate risk of OHSS (\<18 recovered oocytes) which performed GnRH trigger and rescue protocol.

Conditions

GnRH Trigger and Rescue Protocol

Outcome Measures

Primary Outcomes (1)

• ongoing pregnancy rate (OPR)

  presence of gestational sac and fetal hearts beats showed on unltrasonography 7/8 weeks after embryo transfer

  2013-2018

Study Arms (1)

patients underwent "rescue protocols" and fresh embryotransfer

they were patients with good prognosis with a mean age of 34.13 ± 4.42 years, with a good ovarian reserve

Drug: GnRH agonist

Interventions

GnRH agonist DRUG

In High Responder patients (HR) (more than 18 follicles with diameter ≥ 12mm at ovulation induction), the trigger was obtained with triptorelin 0.2 mg sc. In this cohort if less of 18 oocytes were retrieved, patients were considered at intermediate risk of OHSS and fresh transfer was performed. An adequate support of the luteal phase was initiated: HCG 1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily (Rescue protocol).

Also known as: GnRH trigger

patients underwent "rescue protocols" and fresh embryotransfer

Eligibility Criteria

• Age: 18 Years - 38 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

In HR patients (AMH\> 3.5 ng / ml, AFC\> 15 follicles and if more than 18 follicles with diam. 12mm to induction) the trigger was obtained with triptorelin 0.2 mg / sc. In patients considered to be at intermediate risk of OHSS a rescue protocol has been implemented (HCG 1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily) and fresh embryo transfer.

You may qualify if:

• AMH ( antimullerian hormone) \> 3.5 ng / ml, AFC (antral follicles count) \> 15 follicles and if more than 18 follicles with diam. 12mm to induction

You may not qualify if:

• high risk of OHSS ( ovarian hyperstimulation syndrome)

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Related Publications (3)

• 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 RESULT

• 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 RESULT

• Fatemi HM, Garcia-Velasco J. Avoiding ovarian hyperstimulation syndrome with the use of gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2015 Apr;103(4):870-3. doi: 10.1016/j.fertnstert.2015.02.004. Epub 2015 Feb 24.

  PMID: 25724740 RESULT

MeSH Terms

Interventions

Gonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

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

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: March 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share