InfertilityMELISSANCT03817060
CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage
A study testing cryopreservation of embryos at cleavage stage and cryopreservation of embryos at blastocyst stage in people with Infertility, run by Université Libre de Bruxelles.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- cryopreservation of embryos at cleavage stage and cryopreservation of embryos at blastocyst stage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Cycles with testicular sperm extraction
- Preimplantation genetic diagnosis
- Patients with uterine malformations
- Patients with infectious diseases
Trial locations and contacts
No sites are listed yet.
About this study
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)
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.
- Conditions
- Infertility
- Being tested
- cryopreservation of embryos at cleavage stage, cryopreservation of embryos at blastocyst stage
- Keywords
- OHSS, Agonist trigger, freeze-all, blastocyst, cleavage
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryopreservation of embryos at cleavage stageProcedure or surgery
cryopreservation of embryos at cleavage stage (day 3) of embryo development
cryopreservation of embryos at blastocyst stageProcedure or surgery
cryopreservation of embryos at blastocyst stage (day 5 or 6) of embryo development
| Study group | Role | What they receive |
|---|---|---|
| Cleavage | Active comparator | Embryos cryopreserved with vitrification at the cleavage stage (day 3) of embryo development Receives: Procedure: cryopreservation of embryos at cleavage stage |
| Blastocyst | Active comparator | Embryos cryopreserved with vitrification at the blastocyst stage (day 5 or 6) Receives: Procedure: cryopreservation of embryos at blastocyst stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth
Cumulative live birth rate per oocyte retrieval
Measured: within one year of randomisation
Secondary outcomes (1)
Frozen thawed embryo transfer cycles needed to achieve live birth
Number of frozen thawed embryo transfer cycles needed to achieve live birth
Measured: within one year of randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Responsible party
- Principal investigator, Theoni Tarlatzi, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817060
- Sponsor's protocol ID
- SRB_201807_150
- Acronym
- MELISSA
- Status last verified
- Jan 2019
- First submitted
- 7 Dec 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03817060
- Acronym / sponsor ID
- MELISSA / SRB_201807_150
- Conditions
- Infertility
- Keywords
- OHSS, Agonist trigger, freeze-all, blastocyst, cleavage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Study start
- Feb 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cleavage | Active comparator | Procedure: cryopreservation of embryos at cleavage stageEmbryos cryopreserved with vitrification at the cleavage stage (day 3) of embryo development |
| Blastocyst | Active comparator | Procedure: cryopreservation of embryos at blastocyst stageEmbryos cryopreserved with vitrification at the blastocyst stage (day 5 or 6) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Cycles with testicular sperm extraction
- Preimplantation genetic diagnosis
- Patients with uterine malformations
- Patients with infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryopreservation of embryos at cleavage stagecryopreservation of embryos at cleavage stage (day 3) of embryo development | Procedure or surgery | Cleavage |
| cryopreservation of embryos at blastocyst stagecryopreservation of embryos at blastocyst stage (day 5 or 6) of embryo development | Procedure or surgery | Blastocyst |
Primary outcome
Cumulative live birth
Time frame: within one year of randomisation
Cumulative live birth rate per oocyte retrieval
1 secondary outcome
Frozen thawed embryo transfer cycles needed to achieve live birth
Time frame: within one year of randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing cryopreservation of embryos at cleavage stage and cryopreservation of embryos at blastocyst stage in people with Infertility, run by Université Libre de Bruxelles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theoni Tarlatzi (+3225558948, nonika.tarlatzi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative live birth (time frame: within one year of randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.