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Completed

NCT Number: NCT02670304

Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS

Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as one candidate for the treatment or prevention of ovarian hyperstimulation syndrome.

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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 Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

Letrozole was proved to be effective in decreasing the estradiol level of luteal phase after ovum picked up. In this randomized controlled study, investigators try to observe the effectiveness of letrozole on decreasing the incidence of early ovarian hyperstimulation syndrome and vascular epithelium growth factor level of women with high ovarian hyperstimulation syndrome risks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • infertile women undergoing IVF treatment with more than 25 oocytes collected.

Exclusion criteria

  • letrozole contraindications,e.g. severe hepatic and renal dysfunction

Treatment and study plan

letrozole

Drug

letrozole from the day of oocyte retrieval for 5 days

Other names: Femara

Aspirin

Drug

aspirin from the day of oocyte retrieval for 5 days

Primary outcomes

  1. incidence of early OHSS

    Time frame: up to 1 months

Secondary outcomes

  1. vascular endothelial growth factor level

    Time frame: up to 1 months

    vascular endothelial growth factor in pg/ml

  2. incidence of hydrothorax

    Time frame: up to 1 months

  3. incidence of liver dysfunction

    Time frame: up to 1 months

  4. incidence of renal dysfunction

    Time frame: up to 1 months

  5. incidence of electrolytic imbalance

    Time frame: up to 1 months

  6. incidence of hemoconcentration

    Time frame: up to 1 months

  7. incidence of elevated WBC

    Time frame: up to 1 months

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

The Randomized Controlled Trial Study of Letrozole in the Prevention of Medium and Severe Ovarian Hyperstimulation Syndrome in Invitro Fertilization Treatment

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 1, 2016
Registry last updated
Feb 1, 2016

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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