Infertility Urological and Genital Diseases Female infertility
Conditions
Interventions
Conventional controlled ovarian stimulation using a fixed daily doses of 225 IU or 300 IU of recombinant FSH. The total duration of treatment is 6 weeks with 2 weeks of the research medication and up
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female subjects aged between 20 and 38 years, undergoing first, second or third cycle of in vitro fertilisation (IVF)/intra-cytoplasmic sperm injection (ICSI) treatment 2. Subjects must have a regular spontaneous menstrual cycle of 21 to 35 days 3. A basal FSH level of less than or equal to 12 IU 4. Presence of both ovaries 5. Total antral follicle count of between 7 and 22. Subjects who have not had any ovarian surgery in the past. 6. Subjects, who have a body mass index (BMI) of 20 to 35 kg/m^2 7. Subjects must have signed and dated the informed consent document indicating that the subject has been informed all the pertinent aspect of the trial 8. Subjects must be willing and comply with scheduled visits, treatment plan and laboratory tests
Exclusion criteria
Exclusion criteria: 1. Subjects who have an ovarian cyst (greater than 20 mm) or other significant pelvic pathology (uterine anomalies, uterine fibroids, endometrioma) at screening 2. Subjects who have an antral follicle count greater than or equal to 12 with in an ovary and/or an ovary volume of greater than 10 cm^3 on 3D ultrasound 3. Subjects whose infertility is caused by recognised endocrine abnormalities such as polycystic ovarian syndrome, hyperprolactinaemia and abnormal thyroid function 4. Subjects with any contraindications to IVF/ICSI treatment 5. Subjects who are taking concurrent corticosteroids or metformin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of mature oocytes retrieved, measured at about 2 - 3 weeks of starting the research medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of follicles measuring more than 10 mm and more than 14 mm in diameter on the day of human chorionic gonadotropin (hCG) administration 2. Cycle cancellation due to poor ovarian response 3. The number of frozen embryos 4. The prevalence of moderate or severe ovarian hyperstimulation syndrome (OHSS) 5. The clinical and on-going pregnancy rates Measured at 10 weeks at the latest. | — |
Countries
United Kingdom
Outcome results
None listed