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

Miscarriage, Recurrent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05437471
• Other study ID #: GGPM-2019-034
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: June 2022
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Miscarriage, Recurrent
• Recurrence

Intervention

Drug:
• GNRH Analoge, Duphaston, Letrozole
GNRH Analoge, Duphaston, Letrozole

Locations

Country	Name	City	State
Malaysia	UniversitiKMMC	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endometrial abv3-integrin expression expressions	pre and post treatment endometrial abv3-integrin expressions	12 months