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CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03817060
Acronym
MELISSA
Enrollment
128
Registered
2019-01-25
Start date
2019-02-28
Completion date
2021-02-28
Last updated
2019-01-25

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

Conditions

Infertility

Keywords

OHSS, Agonist trigger, freeze-all, blastocyst, cleavage

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.

Interventions

PROCEDUREcryopreservation of embryos at cleavage stage

cryopreservation of embryos at cleavage stage (day 3) of embryo development

PROCEDUREcryopreservation of embryos at blastocyst stage

cryopreservation of embryos at blastocyst stage (day 5 or 6) of embryo development

Sponsors

Aristotle University Of Thessaloniki
CollaboratorOTHER
Université Libre de Bruxelles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cumulative live birthwithin one year of randomisationCumulative live birth rate per oocyte retrieval

Secondary

MeasureTime frameDescription
Frozen thawed embryo transfer cycles needed to achieve live birthwithin one year of randomisationNumber of frozen thawed embryo transfer cycles needed to achieve live birth

Contacts

Primary ContactTheoni Tarlatzi
nonika.tarlatzi@gmail.com+3225558948

Outcome results

None listed

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