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

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

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)

Study Overview

• Status: Completed
• Conditions: Miscarriage, Recurrent
• Intervention / Treatment: Drug: GNRH Analoge, Duphaston, Letrozole

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 56000
    • UniversitiKMMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (GnRH analogue with Aromatase Inhibitor; 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; GNRH Analoge, Duphaston, Letrozole
Active Comparator: Group B (GnRH analogue with Progesterone; 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; GNRH Analoge, Duphaston, Letrozole
Placebo Comparator: Group C (GnRH analogue alone); 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; GNRH Analoge, Duphaston, Letrozole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endometrial abv3-integrin expression expressions	pre and post treatment endometrial abv3-integrin expressions	12 months

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Recurrence; Abortion, Spontaneous; Abortion, Habitual; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Progestins; Letrozole; Dydrogesterone
• Other Study ID Numbers: GGPM-2019-034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No