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

NCT05437471 | Completed DMC

• 1 other identifier: GGPM-2019-034
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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)

Conditions

Miscarriage, Recurrent

Outcome Measures

Primary Outcomes (1)

• endometrial abv3-integrin expression expressions

  pre and post treatment endometrial abv3-integrin expressions

  12 months

Study Arms (3)

Group A (GnRH analogue with Aromatase Inhibitor

ACTIVE COMPARATOR

This group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed by Letroloze 10mg OD for 3 months

Drug: GNRH Analoge, Duphaston, Letrozole

Group B (GnRH analogue with Progesterone

ACTIVE COMPARATOR

This group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed Duphaston 10mg BD by for 3 months

Drug: GNRH Analoge, Duphaston, Letrozole

Group C (GnRH analogue alone)

PLACEBO COMPARATOR

This is a control group. The candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) only.

Drug: GNRH Analoge, Duphaston, Letrozole

Interventions

GNRH Analoge, Duphaston, Letrozole DRUG

GNRH Analoge, Duphaston, Letrozole

Group A (GnRH analogue with Aromatase Inhibitor; Group B (GnRH analogue with Progesterone; Group C (GnRH analogue alone)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

UniversitiKMMC

Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Dydrogesterone; Letrozole

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: All recruited women will be allocated in three groups, and endometrial tissue sampling will be obtained prior to medical intervention assigned during luteal phase depending on their menstrual cycle. All these women will be divided randomly in three groups A, B \& C equally by using the auto-randomized program in SPSS version 21.0.

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: June 29, 2022
• Study Start: January 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: May 30, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Locations

MY (1)