drugset / Trial / NCT04159649

The Outcomes of ICSI Cycles With and Without Letrozole

NCT04159649

Phase 4 Unknown 224 enrolled Mansoura University Zagazig University · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

A variety of genes working together with ovarian hormones conducts and precisely control the process of endometrial receptivity and implantation. Leukemia inhibitory factor and αvβ3 integrin are two markers of implantation with at most importance. Reports have emphasized that these important biomarkers have a great role during the process of embryonic implantation. αvβ3 integrin is one of the adhesion molecules which has a critical role in blastocyst apposition and attachment. Many studies have demonstrated that abnormal expression of αvβ3 integrin is associated with poor reproductive outcomes. Other studies haven't found a strong relation between αvβ3 integrin expression and reproductive outcomes Letrozole is an aromatase inhibitor which has been used in controlled ovarian stimulation especially in women with PCOS . Data suggests that letrozole addition to gonadotropins during ovarian stimulation protocols improve the response of the ovaries to FSH in low responders and increase the number of preovulatory follicles without adversely affect the outcomes. Letrozole is used as an adjuvant therapy in ovarian stimulation protocols. So this study aims to evaluate whether the use of letrozole in combination with gonadotropins and GnRH antagonist is superior to gonadotropins and antagonist alone in women undergoing ICSI treatment. Furthermore, both αvβ3 integrin and leukemia inhibitory factor are important markers of endometrial receptivity and implantation. Therefore, this study aims to assess the correlation between mid-luteal gene expression of both αvβ3 integrin and leukemia inhibitory factor and the clinical outcomes of antagonist cycles with or without letrozole.

Timeline

Start
2019-12-01
Primary completion
2020-12-30
Completion
2020-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Letrozole Other / unclassified 2.5 mg

Indications

No indication recorded.