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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-05-30

Brief Summary

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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)

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Detailed Description

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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

Conditions

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Miscarriage, Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

GNRH Analoge, Duphaston, Letrozole

Intervention Type DRUG

GNRH Analoge, Duphaston, Letrozole

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

Group Type ACTIVE_COMPARATOR

GNRH Analoge, Duphaston, Letrozole

Intervention Type DRUG

GNRH Analoge, Duphaston, Letrozole

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.

Group Type PLACEBO_COMPARATOR

GNRH Analoge, Duphaston, Letrozole

Intervention Type DRUG

GNRH Analoge, Duphaston, Letrozole

Interventions

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GNRH Analoge, Duphaston, Letrozole

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes