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OpenTrials
Completed

NCT Number: NCT05362734

Freeze All Strategy Versus Fresh Embryo Transfer After GnRH Analogue Trigger

Ovarian hyperstimulation syndrome (OHSS) is one of the most dangerous complications of assisted reproduction technology (ART), described in approximatively 3 to 10% of stimulation cycles although an underestimation of the real incidence has been suggested.

The use in clinical practice of GnRH antagonist has made it possible to perform the trigger with GnRH analogues, with the advantage of considerably reducing the risk of OHSS.

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Key information

Conditions

Ovarian Hyperstimulation Syndrome Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Pregnancy Related Urogenital Diseases

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

The main concerns about the trigger with analogue are about obstetric outcomes, since it may increase the Abortion Rate (AR) and reduce the Ongoing Pregnancy Rate (OPR) due to luteal phase deficiency, and on the other hand about oocyte quality and competence.

While in order to maximize the chance of pregnancy at fresh embryo transfer after GnRHa trigger, several studies have focused on the importance of luteal phase support, other authors suggest that the best strategy is freeze-all: cryopreservation of all the obtained embryos and subsequent single embryo transfers.

However, data about oocyte quality, retrieval rate, pregnancy rate and reduced occurrence of complications such as OHSS, especially on the very first embryo transfer, are still scarce.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing ART cycle with antagonist protocol stimulation and trigger with GnRH agonist
  • patients are believed at risk of OHSS at time of trigger based on size and number of follicles developed (≥18 follicles with diameter 12 mm at induction).

Exclusion criteria

  • hypogonadotropic hypogonadism
  • other ART protocols
  • any patient that underwent freeze-all strategy in order to perform pre-implantation genetic testing (PGT)
  • oncological or deferring motherhood freezing procedures

Treatment and study plan

obstetric outcomes after fresh versus cryopreserved embryo transfer

Behavioral

measure of ongoing pregnancy rate, delivery rate, abortion rate, ectopic pregnancy rate, multiple birth rate, ovarian hyperstimulation syndrome incidence, drop out rate

Primary outcomes

  1. ongoing pregnancy rate

    Time frame: 8 years

    number of viable pregnancies that had completed at least 12 weeks of gestation on the total number of ETs performed

  2. delivery rate

    Time frame: 8 years

    number of deliveries of one or more live births over the total performed ET

Secondary outcomes

  1. Other pregnancy outcomes

    Time frame: 8 years

    ectopic pregnancy rate, miscarriage rate, multiple Birth Rate

  2. Safety profile

    Time frame: 8 years

    Severe ovarian hyperstimulation syndrome incidence

  3. the dropout rate

    Time frame: 8 years

    number of cycles in which any live birth (from either ART and/or spontaneous conceive) was not achieved and still some embryos or oocytes had to be thawed

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
May 5, 2022
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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