Female infertility
Conditions
Interventions
The purpose of this study is to compare the clinical results of two hormone replacement regimens for endometrial preparation: estrogen transdermal and oral estrogen at doses of 4.5 mg (6 pumps of 0.75
Drug
Sponsors
Irmandade da Santa Casa de Misericórdia de São Paulo
Projeto ALFA - Aliança de laboratórios de fertilização assistida S.A.
Eligibility
Sex/Gender
Female
Age
22 Years to 49 Years
Inclusion criteria
Inclusion criteria: Women in the menacme with or older than 21 and with or younger than 38 years, when treated with their own eggs or women with or oldr than 21 and with or younger than 50 years when donor eggs or donor embryo. One ou more fifth day (D5) or sixth day (D6) frozen blastocysts. Body mass index (BMI) with or above 18 and with or lower than 35 Kg/m2.
Exclusion criteria
Exclusion criteria: Endocrine or metabolic abnormalities. Serum progesterone concentrations higher than 1 ng / mL, on the day the study started, between the 2nd and 3rd day of the menstrual cycle. Endometrial thickness higher then 5 mm at the beginning of the study, between the 2nd and 3rd day of the menstrual cycle. Tumors: ovaries, breasts, adrenal, pituitary or hypothalamus History of thrombosis or thrombophilia. Alteration of renal or liver function. Endometrial anatomical changes. Hypersensitivity to the active substance or any of the excipients. History of gastroplasty.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find similar chemical and clinical pregnancy rates in the different endometrial preparation regimes. The rate of chemical gestation will be assessed by measuring the quantitative BHG collected after 10 days of embryo transfer. The clinical pregnancy rate will be assessed in case of a positive pregnancy test result (BHCG), 14 days after the test, through obstetric ultrasound.In order to achieve the primary objective of this study, the chi-square test will be used. For the analyzes, appropriate statistical software will be used and p values lower than 0.05 will be considered statistically significant. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find similar thickness and endometrial pattern during the preparation cycle in the different endometrial preparation regimes, verified by transvaginal ultrasound at the beginning of the treatment (between the 2nd and 3rd day of menstruation) and between the 7th and 10th day of endometrial preparation. For descriptive analysis, clinical characteristics will be presented as mean and standard deviation for continuous variables and frequencies and percentages for categorical variables.The groups will be compared in order to assess the homogeneity between them using Student's t tests for continuous variables and chi-square or Fisher's exact test for categorical variables. For the analysis, appropriate statistical software will be used and p values lower than 0.05 will be considered statistically significant.;It is expected to find similar cycle cancellation rates in the different endometrial preparation regimes. The cycles will be canceled in the following situations: If the endometrium does not have adequate thickness and pattern (with or higher than 7mm and trilinear aspect) between the 7th and 10th day of endometrial preparation, the dose of estrogen will be increased to 6mg / day or 8mg / day in Groups 1 and 2, respectively and will be reassessed in 5 days. If the endometrium has not yet reached the standard or the appropriate thickness, the cycle will be canceled. In case of a serious adverse reaction, the cycle will be canceled. For descriptive analysis of the data, clinical characteristics will be presented as mean and standard deviation for continuous variables. The groups will be compared in order to assess the homogeneity between them using Student's t tests for continuous variables. For the analyzes, appropriate statistical software will be used and p values lower than 0.05 will be considered statistically significant. ;Espera – se encontrar concentrações séricas de estrogênio semelhantes nos diferentes regimes de preparo de endométrio. As | — |
Countries
Brazil
Contacts
Public ContactMariana Oliva Cassará Carvalho
Sonia Maria Rolim Rosa Lima
Outcome results
None listed