NCT05152667

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

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 354 (estimated)
• Sponsor: Wael Elbanna Clinic · Academic / Other
• Sex: Female
• Age: 42 Years
• Healthy volunteers: —

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

Detailed 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

Conditions

• Adenomyosis
• IVF

Interventions

Type	Name	Description
DEVICE	levonorgestrel-releasing intrauterine device (LNG-IUS)	Intervention is administered proceeding the ICSI

Timeline

• Start date: 2021-11-27
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2021-12-10
• Last updated: 2021-12-10

Locations

1 site across 1 country: Egypt