Skip to content

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

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05152667
Enrollment
354
Registered
2021-12-10
Start date
2021-11-27
Completion date
2022-07-31
Last updated
2021-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis, IVF

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

Interventions

Intervention is administered proceeding the ICSI

Sponsors

National Research Centre, Egypt
CollaboratorOTHER
Wael Elbanna Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 42 Years

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).

Design outcomes

Primary

MeasureTime frameDescription
ongoing pregnancyup 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

MeasureTime frameDescription
Occurance of abortion or ectopicup to 13 weeks gestationRecording 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
Recording the baseline characteristics of the study participantsBefore study interventionage

Countries

Egypt

Contacts

Primary ContactWael Saad Saad El Banna El Banna, MD
dr.wael.ss.elbanna@gmail.com+2 01227760402
Backup ContactEslam Fathy Fathy, M.Sc.
eslam.f486@gmail.com01092586140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026