Female Infertility
Conditions
Interventions
Schedule of menstruation with oral contraceptive pills for all study patients (study and control group, total: 60 patients)
The recruitment of patients will occur between 20 and 40 days before the Ovarian Stimulation (EO), in the follicular phase of the menstrual cycle of the cycle that precedes the one of controlled ovari
All patients (60) will be instructed to use oral contraceptive pills (ethinyl estradiol 30 mcg and Levonorgestrel 150 mcg) for 15 to 30 days and stop. On the fifth day without pills, women will underg
Women will be allocated randomly in one of two groups:
Group 1 (30 patients): Efficient and cost-effective ovarian stimulation: Clomiphene citrate: 50 mg per day, orally, starting on the first day of
Corifolitropin alfa: 100 mcg, subcutaneous route, single dose, on the first day of ovarian stimulation
Human urinary chorionic gonadotrophin (hCG): 200 international units per day (0.4 ml), subcutaneously, daily from the eighth day of ovarian stimulation, for patients who did not meet the ovulation tri
Monitoring: it will be performed with transvaginal ultrasonography to count and measure the ovarian follicles and measure the endometrial thickness and when there is a follicle greater than or equal t
The triggering will be performed on the night of the same or the following day of observation of 3 follicles greater or equal to 17 mm. We will use triptorelin 0.2 mg subcutaneously and the collection
Drug
Other
E02.875.800.976
Sponsors
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Laboratório de Ginecologia e Obstetricia do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
FAEPA: Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
INCT - Institutos Nacionais de Ciência e Tecnologia
Eligibility
Sex/Gender
Female
Age
18 Years to 38 Years
Inclusion criteria
Inclusion criteria: Infertile women; risk of ovarian hyperstimulation syndrome; between 18 and 38 years; antral follicle count between 20 and 39
Exclusion criteria
Exclusion criteria: Weight less than 60 Kg or greater than 80 kg; partner with spermogram showing total sperm count less than 1 million; do not accept to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presentation of the number of mature eggs captured (MII), evaluated by the embryologist on the day of collection of the eggs | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Presentation of the number of cases of ovarian hyperstimulation syndrome requiring hospitalization, as assessed by the number of hospitalized patients;Expected outcome 2: Presentation of the total number of ovules collected. Evaluated by the embryologist;Expected outcome 3: Presentation of the number of embryos formed. Evaluated by the embryologist;Expected outcome 4: Presentation of the number of embryos of excellent morphological quality two days after fertilization. Evaluated by the embryologist;Expected outcome 5: Presentation of the total number of injections required for treatment. Evaluated by the number of injections counted by the protocol used in each patient;Expected outcome 6: Verification of the participants' satisfaction with the treatment through an interview satisfaction scale;Expected outcome 7: Verification of the cumulative proportion of women who had a positive pregnancy test (clinical pregnancy, ongoing pregnancy, greater than 20 weeks of gestational age, and live birth), with all embryo transfer in progress from uptake subsequent to Ovarian Stimulation;Expected outcome 8: Checking the average number of hospital visits for treatment;Expected outcome 9: Verification of serum estradiol and progesterone concentrations on the day of ovulation triggering | — |
Countries
Brazil
Contacts
Public ContactPaula Navarro
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed