Infertility
Conditions
Brief summary
This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled ovarian stimulation using clomiphene citrate, letrozole, and low-dose hMG on the number of oocytes retrieved.
Interventions
DRUGCOOL-COS
Controlled ovarian stimulation will start on the second or third day of a menstrual cycle: * Oral clomiphene citrate: 100 mg/day until the day of the triggering. * Oral letrozole: 7.5 mg/day during the first 5 days of the controlled ovarian stimulation. * hMG: 150 IU every other day beginning on the day 6 of the controlled ovarian stimulation. The triggering will be performed using urinary hCG (5,000 IU subcutaneous). * 1-2 days after the identification of one follicle ≥ 17 mm * 0-1 days after the identification of one follicle ≥ 19 mm.
Sponsors
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women scheduled to controlled ovarian stimulation for oocyte retrieval. * Body mass index: 18-35 Kg/m2. * Ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle \>10mm and serum estradiol ≥ 40 pg/L). * Signing an informed consent.
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of oocytes retrieved | 12 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of embryos | 17 days |
| Ovarian hyper-stimulation syndrome | 1 month |
Countries
Brazil
Outcome results
None listed