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

Infertility Clinical Trial

— MELISSA  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03817060
• Other study ID #: SRB_201807_150
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: February 2021

Study information

• Verified date: January 2019
• Source: Université Libre de Bruxelles
• Contact: Theoni Tarlatzi
• Phone: +3225558948
• Email: nonika.tarlatzi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: February 2021
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• cryopreservation of embryos at cleavage stage
cryopreservation of embryos at cleavage stage (day 3) of embryo development
• cryopreservation of embryos at blastocyst stage
cryopreservation of embryos at blastocyst stage (day 5 or 6) of embryo development

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Université Libre de Bruxelles	Aristotle University Of Thessaloniki

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative live birth	Cumulative live birth rate per oocyte retrieval	within one year of randomisation
Secondary	Frozen thawed embryo transfer cycles needed to achieve live birth	Number of frozen thawed embryo transfer cycles needed to achieve live birth	within one year of randomisation