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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05437471
Other study ID # GGPM-2019-034
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date May 30, 2022

Study information

Verified date June 2022
Source Universiti Kebangsaan Malaysia Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the abv3-integrin expression in endometrium tissue among RIF women between the GnRH analogue with Aromatase Inhibitor (Group A) , GnRH analogue with progesterone (Group B) and GnRH analogue alone as control group (Group C)


Description:

i. To determine the abv3-integrin expression isolated from endometrium tissue from women with RIF prior to medical therapy. ii. To determine the abv3-integrin expression isolated from endometrium tissue from Group A, Group B and Group C following the medical therapy. iii. To compare the abv3-integrin expression from endometrium tissue obtained from Group A, B and C following the medical therapy. iv. To compare the implantation rates among Group A, B and C following the medical therapy. v. To compare the ongoing pregnancy among Group A, B and C following the medical therapy


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date May 30, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Women of 18 to 40 years of age - No significant pre-existing major medical. - Diagnosed as recurrent implantation failure - at least two or more failure of achieving pregnancy following embryo transfer (ET) despite the optimum endometrial thickness and good quality of embryo (unexplained). - Regular menstrual cycle atleast 3 months prior to treatment - Not taking any hormonal treatment for atlest 3months prior to recruitment - Agreed to participate Exclusion Criteria: - Concurrent significant pre-existing major medical conditions such as uncontrolled diabetes, active systemic lupus erythematosus (SLE) or Anti Phospholipid Syndrome (APS) that will interfere with implantation. - Poor quality of embryo - Suboptimal endometrial thickness(<8mm) during the embryo transfer (ET). - On hormonal therapy prior to recruitment. - Not agreed to participate

Study Design


Intervention

Drug:
GNRH Analoge, Duphaston, Letrozole
GNRH Analoge, Duphaston, Letrozole

Locations

Country Name City State
Malaysia UniversitiKMMC Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary endometrial abv3-integrin expression expressions pre and post treatment endometrial abv3-integrin expressions 12 months
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