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

N

National University of Malaysia (UKM)

Status

Completed

Conditions

Miscarriage, Recurrent

Treatments

Drug: GNRH Analoge, Duphaston, Letrozole

Study type

Interventional

Funder types

Other

Identifiers

NCT05437471
GGPM-2019-034

Details and patient eligibility

About

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)

Full 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

Enrollment

39 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

39 participants in 3 patient groups, including a placebo group

Group A (GnRH analogue with Aromatase Inhibitor
Active Comparator group
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
Treatment:
Drug: GNRH Analoge, Duphaston, Letrozole
Group B (GnRH analogue with Progesterone
Active Comparator group
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
Treatment:
Drug: GNRH Analoge, Duphaston, Letrozole
Group C (GnRH analogue alone)
Placebo Comparator group
Description:
This is a control group. The candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) only.
Treatment:
Drug: GNRH Analoge, Duphaston, Letrozole

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems