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

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