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

NCT03817060 | Unknown

• 1 other identifier: SRB_201807_150
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cumulative live birth

  Cumulative live birth rate per oocyte retrieval

  within one year of randomisation

Secondary Outcomes (1)

• Frozen thawed embryo transfer cycles needed to achieve live birth

  within one year of randomisation

Study Arms (2)

Cleavage

ACTIVE COMPARATOR

Embryos cryopreserved with vitrification at the cleavage stage (day 3) of embryo development

Procedure: cryopreservation of embryos at cleavage stage

Blastocyst

ACTIVE COMPARATOR

Embryos cryopreserved with vitrification at the blastocyst stage (day 5 or 6)

Procedure: cryopreservation of embryos at blastocyst stage

Interventions

cryopreservation of embryos at cleavage stage PROCEDURE

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

Cleavage

cryopreservation of embryos at blastocyst stage PROCEDURE

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

Blastocyst

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Université Libre de Bruxelles: lead
• Aristotle University Of Thessaloniki: collaborator

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Theoni Tarlatzi

CONTACT

+3225558948; nonika.tarlatzi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: January 25, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: January 25, 2019

Record last verified: 2019-01