Ambispective Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin

IVF Clinical Trial

Official title: Ambispective Comparative Cohort Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin on ICSI and Vitrified-Warmed Embryo Transfer Outcomes in Women With Adenomyosis

Status Recruiting

Clinical Trial Summary

The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms

Clinical Trial Description

The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms:

Arm 1: Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI Arm 2: Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI Primary and secondary key measurements will be used in the study.

The primary measures will include:

• Presence of intrauterine gestational sac at 12 weeks

• Presence of fetal heart pulsation at 12 weeks

The secondary key measures will include:

• Occurance of abortion in the 1st trimester

• Appearance of ectopic pregnancy diagnosis by:

Ultrasound Serum β-HCG level Symptoms of pain and bleeding

• Two serum β-HCG levels in 48hrs interval to emphasis biochemical pregnancy

• Recording the the baseline characteristics of the study participants ;

Related Conditions & MeSH terms

• Adenomyosis
• IVF

• NCT number: NCT05152667
• Study type: Observational
• Source: Wael Elbanna Clinic
• Contact: Wael Saad Saad El Banna El Banna, MD
• Phone: +2 01227760402
• Email: dr.wael.ss.elbanna@gmail.com
• Status: Recruiting
• Start date: November 27, 2021
• Completion date: July 2022