The therapy is intended to treat infertility that is caused by declining egg quality that occurs with advanced maternal age. The purpose of this pilot trial is to optimize the therapeutic protocol. This will result in standardization of the therapeutic regimen. Once this standardization has been achieved, a statistically powered trial will be performed to test the efficacy of the therapy for increasing the rates of pregnancy and healthy live borns.
Conditions
Interventions
Trade Name: Decapeptyl
Product Name: Decapeptyl
Pharmaceutical Form: Dispersion for injection
Sponsors
Pannon Reprodukciós Intézet B.1.2
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age 35-44 ? (1) One year or more of infertility that occurred under the age of 35, or 6 months or more of infertility since the age of 35; or (2) one or more previous miscarriages that occurred at age 35 or over. Miscarriages must be either idiopathic, or attributable to autosomal aneuploidy; or (3) one or more trisomic pregnancies that occurred over age 35 ? FSH =13 and =40 IU/L on Day 3 of Cycle 0. ? Regular menstrual cycles of 15-32 days duration. ? Levels of Anti-Müllerian Hormone (AMH) between 0.1 and 1.0 ng/ml ? Patency of both fallopian tubes Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • BMI less than 18 or more than 32 • Confounding untreated infertility conditions: maternal karyotypic abnormalities if there is a history of RPL; PCOS; or untreated antiphospholipid, lupus anticoagulant, hypothyroidism, hyperthyroidism, or hyperprolactinemia • Uncorrected abnormal uterine anatomy that would preclude pregnancy or would be likely to result in pregnancy losses • Endometritis • Medical contraindications to pregnancy • Anti-cholesterol medications • Previous chemotherapy or pelvic radiation for cancer • Known hypersensitivity to GnRHa, FSH, hCG, E2, or progesterone medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) normalize FSH to young levels for each phase of the three cycles of HNT in both the follicular (FP) and luteal (LP) phases; (2) achieve normal follicle growth and ovulation; (3) observe normal menstrual function each cycle; (4) Preliminary assessments of safety by regular monitoring comprised of physician examinations, ultrasounds and blood tests, and frequent communications with the fertility treatment staff.;Secondary Objective: (1) Achievement of pregnancy at end of treatment regimen (2) lengthen the FP to approximate the duration of the FP that is typically experienced by a young and fertile woman. (3) Normalization of E2 levels across FP and LP of Cycles 1, 2, and 3.;Primary end point(s): (1) Serum FSH levels throughout Cycles 0, 1, 2, and 3 (2) kinetics of follicle growth in vaginal ultrasounds (u/s) and via E2 levels during late FP; confirmed ovulation via serum preogsterone and u/s (3) measurement of endometrial thickness in U/s; measurement of FP and LP length; reports of patient on menstrual flow vs. that of untreated cycles (4) Preliminary assessments of safety by regular monitoring comprised of physician examinations, ultrasounds and blood tests, and frequent communications with the fertility treatment staff.;Timepoint(s) of evaluation of this end point: (1) Serum FSH levels early, mid, and late FP and LP in Cycles 0, 1, 2, and 3 (2) Every other day or every day u/s to record follicular diameters, and serum E2 levels ; serum preogsterone and u/s for confirmation of corpora lutea 3 days post hCG shot (3) endometrial thickness u/s in FP; measurement of FP and LP length by comparing day of LH surge/hCG shot to LMP in Cycles 0, 1, 2, and 3; reports of patient on menstrual flow vs. that of untreated cycles (4) Safety monitoring will occur throughout all 4 cycles of trial participation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) hCG pregnancy test at end of treatment regimen (2) FP length in Cycles 0, 1, 2, and 3 (3) Normalization of E2 levels across FP and LP of Cycles 1, 2, and 3;Timepoint(s) of evaluation of this end point: (1) hCG pregnancy test at end of LP in Cycle 3 (2) Compare differences in duration between day of LH surge/hCG shot and LMP in each of Cycles 0, 1, 2, and 3. (3) Measurement of serum E2 levels in early, mid and late LP in Cycles 1, 2, and 3 vs. Cycle 0 | — |
Countries
Hungary
Contacts
Public ContactAttila Török, MD
Pannon Reprodukciós Intézet
Outcome results
None listed