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

• Conditions: Adenomyosis; IVF
• Interventions: Device: levonorgestrel-releasing intrauterine device (LNG-IUS)

• Registration Number: NCT05152667
• Lead Sponsor: Wael Elbanna Clinic

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

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-13
• Study Start: 2021-11-27
• Study First Submitted QC: 2021-11-27
• Last Update Submitted: 2021-11-27
• Study First Posted: 2021-12-10
• Last Update Posted: 2021-12-10
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 354

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	levonorgestrel-releasing intrauterine device (LNG-IUS)	Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI

Primary Outcome Measures

Name	Time	Method
ongoing pregnancy	up to 13 weeks gestation	- 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

Secondary Outcome Measures

Name	Time	Method
Recording the baseline characteristics of the study participants	Before study intervention	BMI in kg/m\^2
Occurance of abortion or ectopic	up to 13 weeks gestation	Recording the following for the two arms of the study: Occurance of abortion in the 1st trimester Appearance of ectopic pregnancy diagnosis Two serum β-HCG levels in 48hrs interval

Trial Locations

Locations (1)

Wael Elbanna Clinic; 🇪🇬 Cairo, Egypt