Letrozole in Induction of Abortion of Anembryonic Pregnancy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: single dose letrozole tablets starting from the first of January, patients will receive a single dose of letrozole (20 mg) two days, before starting misoprostol administration. Placebo tables with a similar appearance to letrozole will be administered the day before misoprostol administration and on the day of misoprostol administration. |
Drug: Letrozole tablets
Letrozole is a third-generation non-steroidal aromatase inhibitor
Drug: Misoprostol Tabets
a synthetic prostaglandin medication
Other Names:
Drug: Placebo tablets
Placebo tables with a similar appearance to letrozole
|
Active Comparator: multiple dose letrozole tablets starting from the first of January, patients will receive 10 mg letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration. |
Drug: Letrozole tablets
Letrozole is a third-generation non-steroidal aromatase inhibitor
Drug: Misoprostol Tabets
a synthetic prostaglandin medication
Other Names:
|
Active Comparator: misoprostol tablets starting from the first of January, patients will receive placebo tablets with a similar appearance to letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration. |
Drug: Misoprostol Tabets
a synthetic prostaglandin medication
Other Names:
Drug: Placebo tablets
Placebo tables with a similar appearance to letrozole
|
Outcome Measures
Primary Outcome Measures
- Complete abortion [2 days]
no emergency or elective curettage was necessary until next menstruation
Secondary Outcome Measures
- Induction-to-abortion interval [2 days]
the interval between administration of misoprostol)
- Adverse effects of Misoprostol [2 days]
diarrhea, abdominal cramps, fever and sweating.
- Adverse effects of Letrozole [2 days]
hot flushes, drowsiness and nausea.
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cairo University | Cairo | Egypt | 12613 |
Sponsors and Collaborators
- Cairo University
Investigators
- Principal Investigator: Marwa M Abdalla, MD, Kasralainy teaching hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- Letrozole and abortion