Infertility, Female Clinical Trial
— TEMPEROfficial title:
Open Randomized Study Comparing Clinical Efficacy of Corifollitropin Alfa (Elonva) in Combination With Menotropin (Merional) With Follitropin and Lutropin Alfa (Pergoveris) for Ovarian Stimulation in Expected Suboptimal Responders
In an opened randomized study of women undergoing in vitro fertilization with expected suboptimal response to controlled ovarian stimulation (Poseidon Group 2b) investigators will examine clinical efficacy and safety of two stimulation protocols: Corifollitropin alfa (Elonva) in combination with menotropin (Merional) versus Follitropin alfa and lutropin alfa (Pergoveris).
Status | Completed |
Enrollment | 32 |
Est. completion date | September 10, 2019 |
Est. primary completion date | November 2, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years to 41 Years |
Eligibility |
Inclusion Criteria: - Female age between 35-41 years; - BMI 17,5-30 kg/m2; - Expected suboptimal responders (according to Poseidon classification, 2016, Group 2b): patients with suboptimal ovarian reserve prestimulation parameters in terms of antimüllerian hormone (AMH) and antral follicle count (AFC): AFC 5-9, AMH =0.8 ng/mL; - Early follicular phase follicle stimulating hormone (FSH) =15 IU/L; - Presence of viable spermatozoa in partner's sperm; - Signed informed consent. Exclusion Criteria: - Pre-existing medical condition preventing or interfering with IVF treatment: any clinically significant systemic disease; inherited or acquires thrombophilia and thromboembolism; endocrine or metabolic abnormalities; moderate or severe impairment of renal or hepatic function; any oncological diseases in anamnesis; known history of recurrent miscarriage, abnormal karyotype of both partners; currently active pelvic inflammatory disease; - Abnormal IVF screening tests: Papanicolaou test, Syphilis, HIV 1&2, Hepatitis B, Hepatitis C, Chlamydia, and Gonorrhea; - Presence of uterine pathology: Asherman's Syndrome, endometrial polyps, nodus form of adenomyosis or uterine fibroids =3 mm in diameter; - Visualization of ovarian cysts =25 mm, endometriomas or hydrosalpinx; - One or more follicles =8 mm on randomization day. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Biochemical pregnancy rate | positive ß-hCG test (=30 IU/L) following ET without clinical pregnancy confirmation | 3-4 weeks after ET | |
Other | Fertilization rate | number of two-pronuclear zygotes on day 1 after fertilization | 1 day after OPU | |
Other | Embryo quality | number of best and good quality embryos per transfer | 3-5 days after oocyte recovery | |
Other | Cost-effectiveness of COS | ratio of total cost of stimulation (on investigated drugs) to the number of patients with clinical pregnancy | 6-7 weeks after randomization | |
Primary | Number of cumulus-oocyte complexes (COCs) | Number of COCs, obtained during oocyte pick up (OPU), after controlled ovarian stimulation (COS) in two protocols | 3-4 weeks after ET | |
Secondary | Duration of stimulation | total days of COS: from the first gonadotropins administration to ovulation triggering | 2-4 weeks after randomization | |
Secondary | Number of follicles at the end of stimulation | measured for follicles =17 mm and =14 mm | 2-4 weeks after randomization | |
Secondary | Dose adjustment frequency | number of participants with menopausal or recombinant human follicle stimulating hormone (FSH) dose increase | 2-4 weeks after randomization | |
Secondary | Number of participants with optimal or suboptimal response to COS | = 5 COCs at at oocyte recovery day | 2-4 weeks after randomization | |
Secondary | Number of mature (MII) oocytes | assessment is done only for ICSI cycles at oocyte recovery day | 2-4 weeks after randomization | |
Secondary | Cycle cancellation rate | number of cancelled cycles during COS (no response), at OPU (premature ovulation, absence or degradation of COCs), during in vitro cultivation (fertilization failure, inadequate embryo quality) or due to other reasons (adverse events, ovarian hyperstimulation syndrome (OHSS), withdrawal) | 6-7 weeks after randomization | |
Secondary | Frequency of side reactions | number of patients with local reactions (redness, itching, swelling or pain) or abdominal discomfort evaluated using visual analogue scale at the end of COS and at ET day | 2-4 weeks after randomization | |
Secondary | Implantation rate | ratio of the number of intrauterine gestational sacs to the number of transferred embryos | 3-4 weeks after ET | |
Secondary | Clinical pregnancy rate | presence of intrauterine gestational sac at transvaginal ultrasound measured per embryo transfer | 5-6 weeks after randomization |
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