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RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER

RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER AFTER TRIGGER WITH ANALOGS OF GNRH: THE HUMANITAS PROTOCOL

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03837223
Enrollment
271
Registered
2019-02-12
Start date
2013-03-01
Completion date
2016-12-31
Last updated
2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GnRH Trigger and Rescue Protocol

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.

Interventions

DRUGGnRH 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).

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
ongoing pregnancy rate (OPR)2013-2018presence of gestational sac and fetal hearts beats showed on unltrasonography 7/8 weeks after embryo transfer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026