Study Results
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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UNKNOWN
PHASE4
224 participants
INTERVENTIONAL
2019-12-01
2020-12-30
Brief Summary
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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.
Detailed Description
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Leukemia inhibitory factor and αvβ3 integrin are two markers of implantation with at most importance. Reports have emphasized that these important bio-markers have a great role during the process of embryonic implantation . Both are expressed in the epithelial cells during the mid-secretory phase of the menstrual cycle in healthy fertile women and their absence is associated with infertility and recurrent pregnancy loss .
Leukemia inhibitory factor is a class of cytokines which plays a key role in the process of implantation in both human and animals . Studies suggest that absence of leukemia inhibitory factor in the endometrium has a negative impact on embryo 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.
The study by Miller and his colleagues suggested that letrozole might improve αvβ3 integrin expression with possible increase in pregnancy and implantation rate. They suggested that, this drug may be a useful adjunct therapy during IVF protocols .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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letrozole, gonadotropins and fixed GnRH antagonist
letrozole (2.5 mg) will be given from the second day of the cycle and for 5 days, gonadotropins will be given from the third day of the cycle and GnRH antagonist will be added from the six day of the cycle for controlled ovarian stimulation in IVF (interventional group). Participant will be exposed to mid luteal endometrial sample in the pretreatment cycle. couples will be asked to use condom in the pretreatment cycle.
Letrozole 2.5Mg Tablet
Gonadotropins with or letrozol in fixed Gn RH antagonist IVF protocol
Gonadotropins
Gonadotropins without letrozol in fixed Gn RH antagonist IVF protocol
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.
gonadotropins and fixed GnRH antagonist (control group).
gonadotropins will be given from the third day of the cycle and GnRH antagonist will be added from the six day of the cycle for controlled ovarian stimulation in IVF(control group). Participant will be exposed to mid luteal endometrial sample in the pretreatment cycle. couples will be asked to use condom in the pretreatment cycle.
Gonadotropins
Gonadotropins without letrozol in fixed Gn RH antagonist IVF protocol
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.
Interventions
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Letrozole 2.5Mg Tablet
Gonadotropins with or letrozol in fixed Gn RH antagonist IVF protocol
Gonadotropins
Gonadotropins without letrozol in fixed Gn RH antagonist IVF protocol
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Regular menstrual cycle (25-35).
* Women undergoing ICSI cycle
* Women who will refuse to participate in in the study.
* ICSI cycles with fresh or frozen TESE samples.
Exclusion Criteria
* Women who had unilateral oophorectomy.
* Women who had uterine abnormality or pathology.
18 Years
40 Years
FEMALE
No
Sponsors
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Zagazig University
OTHER_GOV
Mansoura University
OTHER
Responsible Party
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Ahmed Gibreel
Assistant professor
Principal Investigators
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Eman ElGindy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Zagazig
Locations
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Mansoura University
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Ahmed Gibreel
Role: primary
Other Identifiers
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ZU-IRB
Identifier Type: -
Identifier Source: org_study_id