Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders

• Status: Completed
• Trial end date: 2019-09-10
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
• Treatments: Follicle Stimulating Hormone; Menotropins

Criteria

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.