RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER

NCT ID: NCT03837223

Last Updated: 2019-02-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

271 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-01

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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GnRH Trigger and Rescue Protocol

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

GnRH agonist

Intervention Type 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).

Interventions

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GnRH agonist

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).

Intervention Type DRUG

Other Intervention Names

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GnRH trigger

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

high risk of OHSS ( ovarian hyperstimulation syndrome)
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type RESULT
PMID: 25069504 (View on PubMed)

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.

Reference Type RESULT
PMID: 21450755 (View on PubMed)

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.

Reference Type RESULT
PMID: 25724740 (View on PubMed)

Other Identifiers

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trigger

Identifier Type: -

Identifier Source: org_study_id

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