Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
Study NCT ID:
NCT05152667
Status:
UNKNOWN
Last Update Posted:
2021-12-10
First Post:
2021-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ambispective Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin
Sponsor:
Wael Elbanna Clinic
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: