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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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IVF, Adenomyosis

Intervention / Treatment
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* Device: levonorgestrel-releasing intrauterine device (LNG-IUS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Patients ≤42 years old at the time of starting ICSI cycle Cryopreserved embryo transfer cycles The presence of at least one good cryopreserved day 3 embryo. Exclusion Criteria: Transfer of a poor-quality embryo (grades 3 or 4) History of myomectomy Pelvic ultrasound that showed the presence of uterine fibroids, a hydrosalpinx or endometrial polyps (all known causes of implantation failure).

Ages Eligible for Study
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Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1<br>Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI | Device: levonorgestrel-releasing intrauterine device (LNG-IUS)<br>* Intervention is administered proceeding the ICSI<br>* Other names: oral progestin Dienogest;|
| Arm 2<br>Women with adenomyosis pretreated with oral progestin Dienogest and proceeding with the ICSI | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 β-HCG levels in 48hrs interval | up to 13 weeks gestation | 
| Recording the baseline characteristics of the study participants | age | Before study intervention | 
| Recording the baseline characteristics of the study participants | BMI in kg/m^2 | Before study intervention |