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

Primary Purpose

Miscarriage, Recurrent

Status

Completed

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

GNRH Analoge, Duphaston, Letrozole

About this trial

This is an interventional supportive care trial for Miscarriage, Recurrent

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

UniversitiKMMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A (GnRH analogue with Aromatase Inhibitor

Group B (GnRH analogue with Progesterone

Group C (GnRH analogue alone)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

endometrial abv3-integrin expression expressions

pre and post treatment endometrial abv3-integrin expressions

Secondary Outcome Measures

Full Information

NCT ID

NCT05437471

First Posted

March 29, 2022

Last Updated

June 24, 2022

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

1. Study Identification

Unique Protocol Identification Number

NCT05437471

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

December 30, 2021 (Actual)

Study Completion Date

May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Miscarriage, Recurrent

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A (GnRH analogue with Aromatase Inhibitor

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group B (GnRH analogue with Progesterone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group C (GnRH analogue alone)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GNRH Analoge, Duphaston, Letrozole

Intervention Description

GNRH Analoge, Duphaston, Letrozole

Primary Outcome Measure Information:

Title

endometrial abv3-integrin expression expressions

Description

pre and post treatment endometrial abv3-integrin expressions

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

UniversitiKMMC

City

Kuala Lumpur

ZIP/Postal Code

56000

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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