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Freeze All Strategy Versus Fresh Embryo Transfer After GnRH Analogue Trigger

Sponsor
Istituto Clinico Humanitas (Other)
Overall Status
Completed
CT.gov ID
NCT05362734
Collaborator
(none)
1,548
Enrollment
108
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: obstetric outcomes after fresh versus cryopreserved embryo transfer

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 are still scarce.

Study Design

Study Type:
Observational
Actual Enrollment :
1548 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Freeze All Strategy Versus Fresh Embryo Transfer After GnRH Analogue Trigger
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
fresh embryo transfer

measure: time to live birth

Behavioral: obstetric 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
cryopreserved embryo transfer

measure: time to live birth

Behavioral: obstetric 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

Outcome Measures

Primary Outcome Measures

  1. time to live birth [8 years]

    time to live birth in fresh versus cryopreserved embryo transfers

Secondary Outcome Measures

  1. Oocyte Competence [8 years]

    Proportion of oocytes at MII stage

  2. Safety profile [8 years]

    Ovarian hyperstimulation syndrome incidence

  3. Ongoing Pregnancy Rate [8 years]

    ongoing pregnancy rate in fresh versus cryopreserved embryo transfers

  4. Delivery Rate [8 years]

    delivery rate in fresh versus cryopreserved embryo transfers

  5. Abortion Rate [8 years]

    abortion rate in fresh versus cryopreserved embryo transfers

  6. Ectopic Pregnancy Rate [8 years]

    ectopic pregnancy rate in fresh versus cryopreserved embryo transfers

  7. Multiple Birth Rate [8 years]

    multiple birth rate in fresh versus cryopreserved embryo transfers

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Istituto Clinico Humanitas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT05362734
Other Study ID Numbers:
  • 999
First Posted:
May 5, 2022
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome

Study Results

No Results Posted as of May 12, 2022