The Effect of 7 Days of Letrozole Pretreatment Combined With Misoprostol on the Placental and Decidual Tissues

Study Overview
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Brief Summary
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The present study aims at studying the effect of letrozole in early pregnancy in placenta and decidua including the progesterone receptor and the apoptotic factors.

Detailed Description
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Twenty healthy subjects requesting legal surgical abortion up to 63 days gestation will be recruited for this study. They will be randomized to receive either placebo tablets or letrozole 10 mg daily for 7 days before suction evacuation. Suction evacuates which include the placenta and some decidua collected by the procedure in these 20 subjects will be used for the laboratory studies.

Official Title
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The Effect of 7 Days of Letrozole Pretreatment Combined With Misoprostol on the Placental and Decidual Tissues

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Letrozole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The gestational age should be up to 63 days. An ultrasound assessment would be performed to confirm the gestation. The woman is willing and able to participate after the study has been explained Age >18 years old Exclusion Criteria: Criteria for prospective exclusion Any indication of past or present ill health will be considered a contraindication for recruitment to the study. In particular, subjects should not be recruited if any of the following conditions is present: multiple pregnancies uterine fibroids any significant medical disorder intrauterine contraceptive device in situ contra-indications to the use of letrozole or misoprostol Criteria for exclusion from a secondary analysis Situation in which subjects who have been formally admitted to the study could be excluded from a secondary analysis include: the use of drugs other than those prescribed by the investigator for the treatment of possible therapy-related side-effects especially drugs with prostaglandin synthetase inhibitory activity such as salicylates, indomethacin or mefenamic acid any violation of the study protocol essential data missing from the subject's records making it impossible to judge the treatment outcome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Letrozole group<br>Letrozole 10 mg daily for 7 days before suction evacuation | Drug: Letrozole<br>* letrozole 10 mg daily for 7 days before suction evacuation<br>* Other names: Letrozole group;|
| Placebo Comparator: Placebo group<br>Placebo tablets (look identical to letrozole tablets) daily for 7 days before suction evacuation | Drug: Placebo<br>* placebo tablets which look identical to the letrozole tablets for 7 days before suction evacuation<br>* Other names: Placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining. |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apoptosis in the placental and decidual cells as demonstrated by TUNEL assay. |  | 8 days |