Effects of Co-treatment on Endometrial abv3-integrin Expressions in Women With Recurrent Implantation Failure

Not Applicable

Completed

• Conditions: Miscarriage, Recurrent
• Interventions: Drug: GNRH Analoge, Duphaston, Letrozole

• Registration Number: NCT05437471
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

Brief 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)

Detailed 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

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-12-30
• Study First Submitted: 2022-03-29
• Study Completion: 2022-05-30
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-24
• Last Update Submitted: 2022-06-24
• Study First Posted: 2022-06-29
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (GnRH analogue with Aromatase Inhibitor	GNRH Analoge, Duphaston, Letrozole	This group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed by Letroloze 10mg OD for 3 months
Group B (GnRH analogue with Progesterone	GNRH Analoge, Duphaston, Letrozole	This group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed Duphaston 10mg BD by for 3 months
Group C (GnRH analogue alone)	GNRH Analoge, Duphaston, Letrozole	This is a control group. The candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) only.

Primary Outcome Measures

Name	Time	Method
endometrial abv3-integrin expression expressions	12 months	pre and post treatment endometrial abv3-integrin expressions

Trial Locations

Locations (1)

UniversitiKMMC; 🇲🇾 Kuala Lumpur, Malaysia