The Outcomes of ICSI Cycles With and Without Letrozole

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.

Conditions

• EMBRYO IMPLANTATION

Interventions

DRUG

Letrozole 2.5Mg Tablet

Gonadotropins with or letrozol in fixed Gn RH antagonist IVF protocol

DRUG

Gonadotropins

Gonadotropins without letrozol in fixed Gn RH antagonist IVF protocol

PROCEDURE

endometrial sample in the pretreatment cycle

All participant will be exposed to mid luteal endometrial sample in the pretreatment cycle. couples will be asked to use condom in the pretreatment cycle.

Sponsors & Collaborators

• Zagazig University

  collaborator OTHER_GOV

• Mansoura University

  lead OTHER

Principal Investigators

• Eman ElGindy, MD, PhD · Zagazig

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-01

Primary Completion

2020-12-30

Completion

2020-12-30

Countries

• Egypt

Study Locations