Clinical trial NCT05198050: Letrozole in Induction of Abortion of Anembryonic Pregnancy
Official title: Letrozole Plus Misoprostol Versus Misoprostol Alone in Induction of Abortion of Anembryonic Pregnancy:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anembryonic Pregnancy
Keywords: Letrozole
misoprostol
induction of abortion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Some studies suggest the prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion. the aim of the study is to compare the effectiveness of various regimens of letrozole combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with blighted ovum.

Detailed description: Some studies suggest prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion, increases the efficiency of the treatment regimen and also decreases the need for surgical interventions. Some conducted studies have mentioned reinforcing the impact of misoprostol with letrozole, but reaching the ideal dose still needs more studies, so in this study, the investigators will compare the effectiveness of various regimens of letrozole ( 10 mg/d for 3 days or a single dose of 20 mg) combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with a blighted ovum.

Eligibility criteria: Inclusion Criteria:

* first trimester of pregnancy
* pregnancy duration less than 12 weeks based on LMP.
* non-viable fetus (blighted ovum)

Exclusion Criteria:

* No heart disease,
* No asthma
* No History of thromboembolism
* No History of cancer
* No renal failure
* No liver diseases
* History of allergy to misoprostol or letrozole drugs.

Primary outcomes:
measure: Complete abortion
timeFrame: 2 days
Secondary outcomes:
measure: Induction-to-abortion interval
timeFrame: 2 days
measure: Adverse effects of Misoprostol
timeFrame: 2 days
measure: Adverse effects of Letrozole
timeFrame: 2 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Kasralainy teaching hospital
name: Marwa M Abdalla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fouda UM, Sayed AM. Extended letrozole regimen versus clomiphene citrate for superovulation in patients with unexplained infertility undergoing intrauterine insemination: a randomized controlled trial. Reprod Biol Endocrinol. 2011 Jun 21;9:84. doi: 10.1186/1477-7827-9-84.
citation: Abbasalizadeh F, Sahhaf F, Sadeghi-Shabestari P, Mirza-Aghazadeh-Attari M, Naghavi-Behzad M. Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial. J Family Reprod Health. 2018 Mar;12(1):27-33.
citation: Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-323. doi: 10.1097/AOG.0b013e3182073fbf.
citation: Lee VC, Yeung TW, Tang OS, Ng EH, Yeung WS, Ho PC. Effect of letrozole on uterine artery Doppler flow indices prior to first-trimester termination of pregnancy: a randomized controlled trial. Ultrasound Obstet Gynecol. 2012 Oct;40(4):392-7. doi: 10.1002/uog.11115.