CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage (MELISSA)
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cryopreservation of embryos at cleavage stage
cryopreservation of embryos at blastocyst stage
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring OHSS, Agonist trigger, freeze-all, blastocyst, cleavage
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cleavage
Blastocyst
Arm Description
Embryos cryopreserved with vitrification at the cleavage stage (day 3) of embryo development
Embryos cryopreserved with vitrification at the blastocyst stage (day 5 or 6)
Outcomes
Primary Outcome Measures
Cumulative live birth
Cumulative live birth rate per oocyte retrieval
Secondary Outcome Measures
Frozen thawed embryo transfer cycles needed to achieve live birth
Number of frozen thawed embryo transfer cycles needed to achieve live birth
Full Information
NCT ID
NCT03817060
First Posted
December 7, 2018
Last Updated
January 23, 2019
Sponsor
Université Libre de Bruxelles
Collaborators
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT03817060
Brief Title
CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Libre de Bruxelles
Collaborators
Aristotle University Of Thessaloniki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
OHSS, Agonist trigger, freeze-all, blastocyst, cleavage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cleavage
Arm Type
Active Comparator
Arm Description
Embryos cryopreserved with vitrification at the cleavage stage (day 3) of embryo development
Arm Title
Blastocyst
Arm Type
Active Comparator
Arm Description
Embryos cryopreserved with vitrification at the blastocyst stage (day 5 or 6)
Intervention Type
Procedure
Intervention Name(s)
cryopreservation of embryos at cleavage stage
Intervention Description
cryopreservation of embryos at cleavage stage (day 3) of embryo development
Intervention Type
Procedure
Intervention Name(s)
cryopreservation of embryos at blastocyst stage
Intervention Description
cryopreservation of embryos at blastocyst stage (day 5 or 6) of embryo development
Primary Outcome Measure Information:
Title
Cumulative live birth
Description
Cumulative live birth rate per oocyte retrieval
Time Frame
within one year of randomisation
Secondary Outcome Measure Information:
Title
Frozen thawed embryo transfer cycles needed to achieve live birth
Description
Number of frozen thawed embryo transfer cycles needed to achieve live birth
Time Frame
within one year of randomisation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theoni Tarlatzi
Phone
+3225558948
Email
nonika.tarlatzi@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage
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