se of Follitropin Delta associated with Menotropin to induce ovulation in high-risk patients for Poor Response in In Vitro Fertilizatio

Phase 4

• Conditions: Infertility

• Registration Number: RBR-2kmyfm
• Lead Sponsor: Clinica Vidabemvinda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-10
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: