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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05152667
• Other study ID #: Elbanna_001
• Status: Recruiting
• Start date: November 27, 2021
• Est. completion date: July 2022

Study information

• Verified date: August 2021
• Source: Wael Elbanna Clinic
• Contact: Wael Saad Saad El Banna El Banna, MD
• Phone: +2 01227760402
• Email: dr.wael.ss.elbanna[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Gender: Female
• Age group: N/A to 42 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed using both the transvaginal ultrasound study (TVS) and MRI criteria

• Main criteria for sonographic and MRI diagnosis of adenomyosis are:

The appearance of asymmetrical thickening of the myometrium Irregular cystic areas within the myometrium Linear striations radiating out from the myometrium

2. Patients =42 years old at the time of starting ICSI cycle

3. Cryopreserved embryo transfer cycles

4. The presence of at least one good cryopreserved day 3 embryo.

Exclusion Criteria:

1. Transfer of a poor-quality embryo (grades 3 or 4)

2. History of myomectomy

3. Pelvic ultrasound that showed the presence of uterine fibroids, a hydrosalpinx or endometrial polyps (all known causes of implantation failure).

Related Conditions & MeSH terms

• Adenomyosis
• IVF

Intervention

Device:
• levonorgestrel-releasing intrauterine device (LNG-IUS)
Intervention is administered proceeding the ICSI

Locations

Country	Name	City	State
Egypt	Wael Elbanna Clinic	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Wael Elbanna Clinic	National research centre

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ongoing pregnancy	- Recording the following for the two arms of the study: Presence of intrauterine gestational sac at 12 weeks Presence of fetal heart pulsation at 12 weeks	up to 13 weeks gestation
Secondary	Occurance of abortion or ectopic	Recording the following for the two arms of the study: Occurance of abortion in the 1st trimester Appearance of ectopic pregnancy diagnosis Two serum ß-HCG levels in 48hrs interval	up to 13 weeks gestation
Secondary	Recording the baseline characteristics of the study participants	age	Before study intervention
Secondary	Recording the baseline characteristics of the study participants	BMI in kg/m^2	Before study intervention