Skip to content

Freeze All Strategy Versus Fresh Embryo Transfer After GnRH Analogue Trigger

Freeze All Strategy Versus Fresh Embryo Transfer After GnRH Analogue Trigger

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05362734
Enrollment
1396
Registered
2022-05-05
Start date
2012-01-01
Completion date
2020-12-31
Last updated
2023-07-07

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

Conditions

Ovarian Hyperstimulation Syndrome, Pregnancy Related

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.

Detailed description

The main concerns about the trigger with analogue are about obstetric outcomes, since it may increase the Abortion Rate (AR) and reduce the Ongoing Pregnancy Rate (OPR) due to luteal phase deficiency, and on the other hand about oocyte quality and competence. While in order to maximize the chance of pregnancy at fresh embryo transfer after GnRHa trigger, several studies have focused on the importance of luteal phase support, other authors suggest that the best strategy is freeze-all: cryopreservation of all the obtained embryos and subsequent single embryo transfers. However, data about oocyte quality, retrieval rate, pregnancy rate and reduced occurrence of complications such as OHSS, especially on the very first embryo transfer, are still scarce.

Interventions

BEHAVIORALobstetric outcomes after fresh versus cryopreserved embryo transfer

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

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
ongoing pregnancy rate8 yearsnumber of viable pregnancies that had completed at least 12 weeks of gestation on the total number of ETs performed
delivery rate8 yearsnumber of deliveries of one or more live births over the total performed ET

Secondary

MeasureTime frameDescription
Other pregnancy outcomes8 yearsectopic pregnancy rate, miscarriage rate, multiple Birth Rate
Safety profile8 yearsSevere ovarian hyperstimulation syndrome incidence
the dropout rate8 yearsnumber of cycles in which any live birth (from either ART and/or spontaneous conceive) was not achieved and still some embryos or oocytes had to be thawed

Outcome results

None listed

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