Infertility needing In-Vitro fertilisation treatment
Conditions
Interventions
Trade Name: Gonal F
Pharmaceutical Form: Injection*
Sponsors
School of Human Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: --Female subjects aged between 20 and 38 years -Subjects undergoing first, second or third cycle of IVF/ICSI treatment. -Subjects with basal FSH level of 10 or less. -Subjects must have both the ovaries. -Absence of antral follicle count ¡Ý12 with in an ovary and/or an ovary volume of >10cm3 on 3D ultrasound. -Subjects who have not had any ovarian surgery in the past. -Subjects, who have a body mass index (BMI) of 20 to 35 -Subjects in study groups must have a regular spontaneous menstrual cycle of 21 to 35 days. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Subjects who have an ovarian cyst (>20 mm) at the 1st scan in the early follicular phase. It can interfere with ovarian follicle monitoring. -Subjects whose infertility caused by endocrine abnormalities such as poly cystic ovarian syndrome, hyperprolactinemia and abnormal thyroid function. -Subjects with any contraindications to IVF/ICSI treatment. -Subjects, who are taking concurrent corticosteroids/ Metformin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: In addition, this study aims to compare the role of 3D ultrasound to various hormonal markers in predicting a subject's ovarian response to stimulation during IVF treatment.; Primary end point(s): -Ongoing pregnancy rates -Number of mature oocytes retreived ; Main Objective: The principal aim of the study is to compare the efficacy of a fixed daily dose of 150 IU versus 225 IU of recombinant FSH in expected low and intermediate responders during IVF treatment. | — |
Countries
United Kingdom
Outcome results
None listed