Clinical trial NCT05152667: Ambispective Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenomyosis
IVF
Lead sponsor: Wael Elbanna Clinic
Sponsor class: OTHER
Collaborators: name: National Research Centre, Egypt
First posted: 2021-12-10
Enrollment: 354
Sex: FEMALE
Maximum age (years): 42
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include women with adenomyosis, proceeding with the ICSI and pretreated with either:

1. levonorgestrel-releasing intrauterine device (LNG-IUS)
2. Oral progestin "Dienogest"

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

Eligibility criteria: 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).

Primary outcomes:
measure: ongoing pregnancy
timeFrame: up to 13 weeks gestation
Secondary outcomes:
measure: Occurance of abortion or ectopic
timeFrame: up to 13 weeks gestation
measure: Recording the baseline characteristics of the study participants
timeFrame: Before study intervention
measure: Recording the baseline characteristics of the study participants
timeFrame: Before study intervention
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Wael Elbanna Clinic
Study officials:
References: