Letrozole in Induction of Abortion of Anembryonic Pregnancy

Anembryonic Pregnancy Clinical Trial

Official title:

Letrozole Plus Misoprostol Versus Misoprostol Alone in Induction of Abortion of Anembryonic Pregnancy:

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05198050
• Other study ID #: Letrozole and abortion
• Status: Completed
• Phase: N/A
• Start date: April 3, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anembryonic Pregnancy

Intervention

Drug:
• Letrozole tablets
Letrozole is a third-generation non-steroidal aromatase inhibitor
• Misoprostol Tabets
a synthetic prostaglandin medication
• Placebo tablets
Placebo tables with a similar appearance to letrozole

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete abortion	no emergency or elective curettage was necessary until next menstruation	2 days
Secondary	Induction-to-abortion interval	the interval between administration of misoprostol)	2 days
Secondary	Adverse effects of Misoprostol	diarrhea, abdominal cramps, fever and sweating.	2 days
Secondary	Adverse effects of Letrozole	hot flushes, drowsiness and nausea.	2 days