Letrozole in Induction of Abortion of Anembryonic Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-03

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anembryonic Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Letrozole tablets

Intervention Type DRUG

Letrozole is a third-generation non-steroidal aromatase inhibitor

Misoprostol Tabets

Intervention Type DRUG

a synthetic prostaglandin medication

Placebo tablets

Intervention Type DRUG

Placebo tables with a similar appearance to letrozole

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.

Group Type ACTIVE_COMPARATOR

Letrozole tablets

Intervention Type DRUG

Letrozole is a third-generation non-steroidal aromatase inhibitor

Misoprostol Tabets

Intervention Type DRUG

a synthetic prostaglandin medication

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.

Group Type ACTIVE_COMPARATOR

Misoprostol Tabets

Intervention Type DRUG

a synthetic prostaglandin medication

Placebo tablets

Intervention Type DRUG

Placebo tables with a similar appearance to letrozole

Interventions

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Letrozole tablets

Letrozole is a third-generation non-steroidal aromatase inhibitor

Intervention Type DRUG

Misoprostol Tabets

a synthetic prostaglandin medication

Intervention Type DRUG

Placebo tablets

Placebo tables with a similar appearance to letrozole

Intervention Type DRUG

Other Intervention Names

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prostaglandin E1

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No