Infertility
Conditions
Interventions
The control group will be historical and comprised of patients from the Phase 3 study of Follitropin Delta (n=280). In the intervention group, women will have their weight and Anti-Müllerian Hormone a
Drug
Z31.3
Sponsors
Clinica Vidabemvinda
Clinica Vidabemvinda
Eligibility
Sex/Gender
Female
Age
No minimum to 40 Years
Inclusion criteria
Inclusion criteria: Informed consent signed before starting the treatment cycle; Good physical and mental health; Pre-menopausal women aged at least 18 and at most 40 years of age when they sign the consent form and when they start the treatment cycle, in that order; Infertile women diagnosed with tubal, unexplained infertility, endometriosis stage I or II or whose partners have a male factor and are eligible for IVF or intracytoplasmic sperm injection (ICSI) using fresh or frozen semen from the partner or donated; Infertility of at least one year before the start of the study for women up to 37 years old and for at least 6 months for women aged 38 years or more (not applicable if there is already known tubal or male factor); The cycle included should be the individual's first controlled ovarian stimulation cycle for IVF;Regular menstrual cycles lasting between 24 and 35 days, presumably ovulatory; Hysterosalpingography, hysteroscopy, hysterosonography or transvaginal ultrasound documenting uterus with anatomy compatible with pregnancy (that is, without evidence of submucosal or intramural uterine fibroids larger than three centimeters, polyps or congenital anomalies that are associated with reduced chances of pregnancy within one year before the start of the study);Transvaginal ultrasound documenting the presence of both ovaries in an accessible position for egg collection, without clear evidence of other normalities (that is, endometriomas larger than three centimeters or ovaries of very large volume that contraindicate the use of gonadotropins) and normal attachments (that is, without hydrosalpinx) within one year before the start of the study; Serum FSH levels in early follicular false (from the second to the fourth day of the cycle) between 1 IU per L and 15 IU per L, obtained within three months of the beginning of the study; Negative serologies for HIV, HTLV, Hepatitis B (surface antigen and anti-core), Hepatitis C and syphilis, within 6 months of the beginning of the study and Zika virus in the month of the beginning of the cycle; Body mass index between 17.5 and 32 kg per square meter (including both values) at the beginning of the study; Availability to accept a transfer of up to two blastocysts originating from the study cycle within one year after inclusion
Exclusion criteria
Exclusion criteria: known stage III or IV endometriosis; One or more follicles greater than or equal to 10 mm on the day the stimulation starts; History of recurrent miscarriage (three consecutive losses before 24 weeks, excluding ectopic pregnancy); Abnormal karyotype of the woman or partner or semen donor. In cases where the seminal analysis shows a concentration below one million sperm per mL, a Y chromosome microdeletion test with normal results is mandatory; Any significant systemic clinical disease (eg, insulin-dependent diabetes); Any known hereditary or acquired thrombobophilia; Active arterial or venous thromboembollism or severe thrombophlebitis, or history of these events; known porphyria; Any endocrine-metabolic disease (pituitary, adrenal, liver, pancreas and kidney) that may compromise participation in the study, with the exception of well-controlled thyroid disease; Presence of known anti-FSH antibodies (based on history and previous tests and not on tests performed during that study); Known tumors of ovary, breast, uterus, adrenal, pituitary or hypothalamus that contraindicate the use of gonadotropins; Impaired kidney or liver function; Current lactant; Abnormal vaginal bleeding without a definite cause; Abnormal cervical oncotic cytology within three years of the start of the study (unless already treated and resolved); Findings of gynecological exams that reduce the chance of pregnancy (congenital uterine malformations and retained intrauterine devices); Current pregnancy (negative pregnancy test documented at the beginning of the cycle) or contraindication for pregnancy; Current pelvic inflammatory disease; Use of fertility modifiers at the beginning of the study such as DHEA, pills, progestogens or estrogens; Use of hormonal medications (except for thyroid); Known history of chemotherapy (except for gestational trophoblastic neoplasia) or radiation therapy; Current or past drug and alcohol abuse within one year of starting the study (drinking more than 14 units of alcohol per week); Current or past smoking within three months of the start of the study (more than 10 cigarettes per day); Hypersensitivity to any of the inputs used in the study; Have already participated in the study; Use of drugs not yet registered within three months of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: To evaluate the ovarian response, by counting the number of eggs obtained after collection, expecting a reduction in the incidence of poor ovarian response (less than four eggs) by at least 50% in relation to the historical control group;;Outcome 1: | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: To evaluate of the ovarian response, by counting the number of eggs obtained after retrieval, expecting a reduction in the incidence of ovarian hyporesponse (less than eight eggs) by at least 25% in relation to the historical control group; ;Outcome 2:;Expected outcome 3: To evaluate the ovarian response, by counting the number of eggs obtained after retrieval, expecting to increase the incidence of target ovarian response (from eight to 14 eggs) by at least 25% in relation to the historical control group;;Outcome 3;Expected outcome 4: To evaluate the ovarian response, by counting the number of eggs obtained after retrieval, expecting that there will be no increase in the incidence of high ovarian response (15 eggs or more) in relation to the historical control group;;Outcome 4:;Expected outcome 5: To quantify the duration of ovarian stimulation, in days. It is expected that there will be no differences in relation to the control group;;Outcome 5:;Expected outcome 6: To quantify the number of follicles greater than or equal to 17 mm on the last day of stimulation by transvaginal ultrasound, with an expected increase of at least 25% in the number of follicles in relation to the historical control group;;Outcome 6:;Expected outcome 7: To evaluate the serum level of estradiol on the day of ovulation deflagration by the electrochemiluminimetric method, expecting an increase of at least 25% in the value in relation to the historical control group;;Outcome 7:;Expected outcome 8: To measure of endometrial thickness in mm on the day of ovulation trigger using transvaginal ultrasound. It is expected that there will be no differences in relation to the control group; ;Outcome 8:;Expected outcome 9: To quantify zygotes (embryos with 2 cells) by optical microscopy, with an expected increase of at least 25% in the number of follicles in relation to the historical control group;Outcome 9:;Expected outcome 10: Quantify and classify embryos in the cleavage s | — |
Countries
Brazil
Contacts
Public ContactOscar Duarte-Filho
Clinica Vidabemvinda
Outcome results
None listed