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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cleavage

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

Group Type ACTIVE_COMPARATOR

cryopreservation of embryos at cleavage stage

Intervention Type PROCEDURE

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

Blastocyst

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

Group Type ACTIVE_COMPARATOR

cryopreservation of embryos at blastocyst stage

Intervention Type PROCEDURE

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

Interventions

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cryopreservation of embryos at cleavage stage

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

Intervention Type PROCEDURE

cryopreservation of embryos at blastocyst stage

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No