Pregnancy
Conditions
Brief summary
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
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.
Interventions
DRUGPlacebo
placebo tablets which look identical to the letrozole tablets for 7 days before suction evacuation
DRUGLetrozole
letrozole 10 mg daily for 7 days before suction evacuation
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. multiple pregnancies 2. uterine fibroids 3. any significant medical disorder 4. intrauterine contraceptive device in situ 5. 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: 1. 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 2. any violation of the study protocol 3. essential data missing from the subject's records making it impossible to judge the treatment outcome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining. | 8 days |
Secondary
| Measure | Time frame |
|---|---|
| Apoptosis in the placental and decidual cells as demonstrated by TUNEL assay. | 8 days |
Countries
China
Outcome results
None listed