The Outcomes of ICSI Cycles With and Without Letrozole

NCT04159649 | Unknown Phase 4 DMC

• 1 other identifier: ZU-IRB
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• ongoing pregnancy rate.

  Number of pregnant women with viable fetus at 12 weeks gestation per woman randomized

  12 weeks

Secondary Outcomes (7)

• endometrial thickness at day of HCG administration

  9-12 days from first day of menstruation when at least three growing follicle reaches above 18 mm

• estrogen and progesterone levels during day of HCG,

  9-12 days from first day of menstruation when at least three growing follicle reaches above 18 mm

• Rate of implantation

  21 days after embryo transfer

• Rate of clinical pregnancy

  5 weeks after embryo transfer

• miscarriage rate

  20 weeks

Study Arms (2)

letrozole, gonadotropins and fixed GnRH antagonist

EXPERIMENTAL

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.

Drug: Letrozole 2.5Mg Tablet; Drug: Gonadotropins; Procedure: endometrial sample in the pretreatment cycle

gonadotropins and fixed GnRH antagonist (control group).

ACTIVE COMPARATOR

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.

Drug: Gonadotropins; Procedure: endometrial sample in the pretreatment cycle

Interventions

Letrozole 2.5Mg Tablet DRUG

Gonadotropins with or letrozol in fixed Gn RH antagonist IVF protocol

Also known as: Femara

letrozole, gonadotropins and fixed GnRH antagonist

Gonadotropins DRUG

Gonadotropins without letrozol in fixed Gn RH antagonist IVF protocol

gonadotropins and fixed GnRH antagonist (control group).; letrozole, gonadotropins and fixed GnRH antagonist

endometrial sample in the pretreatment cycle PROCEDURE

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).; letrozole, gonadotropins and fixed GnRH antagonist

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged from 18 - 40 years old.
• Regular menstrual cycle (25-35).
• Women undergoing ICSI cycle

You may not qualify if:

• Women younger than 18 or older than 40 years old.
• Women who had unilateral oophorectomy.
• Women who had uterine abnormality or pathology.
• Women who will refuse to participate in in the study.
• ICSI cycles with fresh or frozen TESE samples.

Sponsors & Collaborators

• Mansoura University: lead
• Zagazig University: collaborator

Study Sites (1)

Mansoura University

Al Mansurah, 53111, Egypt

RECRUITING

MeSH Terms

Interventions

Letrozole; Tablets; Gonadotropins

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Eman ElGindy, MD, PhD

  Zagazig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman ElGindy, MD, PhD

CONTACT

01227491143; eman_elgindy2013@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: November 12, 2019
• Study Start: December 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 16, 2019

Record last verified: 2019-11

Locations

EG (1)