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Clinical Trials/NCT03817060
NCT03817060
Unknown
Not Applicable

CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage in a Single Embryo Transfer Setting (MELISSA)

Université Libre de Bruxelles0 sites128 target enrollmentFebruary 2019
ConditionsInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Université Libre de Bruxelles
Enrollment
128
Primary Endpoint
Cumulative live birth
Last Updated
7 years ago

Overview

Brief Summary

Ovarian stimulation for the induction of multifollicular growth by gonadotrophins represents an important part of In Vitro Fertilization (IVF). However, the use of these drugs can be associated with side effects, from which the most common is the Ovarian Hyperstimulation Syndrome (OHSS). Stimulation with gonadotrophins in a Gonadotropin-releasing hormone (GnRH) antagonist cycle rather than a GnRH agonist cycle reduces significantly the risk of OHSS. During stimulation, the best predictor of severe OHSS is the number of follicles >10mm on the day of triggering final oocyte maturation, with the threshold at ≥16 follicles. When this occurs, final oocyte maturation can be induced with a GnRH agonist, reducing further the risk the syndrome. To perform a fresh embryo transfer, 1500 IU human Chorionic Gonadotropin (hCG) can be administered on the day of oocyte retrieval for the luteal support. However, with this procedure there are still some cases of OHSS. To overcome this, it is suggested to combine GnRH agonist triggering with a freeze-all embryos strategy and perform embryo replacement in subsequent frozen-thawed embryo transfer (FET) cycles. Different cryopreservation strategies are been performed according to the procedure of each fertility center, such as cryopreservation at 2 pronuclear (2PN), cleavage or blastocyst stage. The aim of this study is to determine the optimal strategy for the freeze-all cycles and particularly the optimal day for freezing, thawing and transferring the embryos. The hypothesis is that there will increased cumulative live birth rates per started cycle in blastocyst compared to cleavage stage FET cycles.

Registry
clinicaltrials.gov
Start Date
February 2019
End Date
February 2021
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Theoni Tarlatzi

Principal Investigator

Université Libre de Bruxelles

Eligibility Criteria

Inclusion Criteria

  • Patients \<40 years old
  • Indication for In Vitro Fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI)
  • No more than 2 previous failed IVF/ICSI cycles
  • Stimulation in GnRH antagonist cycle
  • Presence of ≥16 follicles of \>10mm on the day of triggering of final oocyte maturation
  • GnRH agonist trigger (triptorelin 0.2mg)

Exclusion Criteria

  • Cycles with testicular sperm extraction
  • Preimplantation genetic diagnosis
  • Patients with uterine malformations
  • Patients with infectious diseases

Outcomes

Primary Outcomes

Cumulative live birth

Time Frame: within one year of randomisation

Cumulative live birth rate per oocyte retrieval

Secondary Outcomes

  • Frozen thawed embryo transfer cycles needed to achieve live birth(within one year of randomisation)

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