A prospective, randomised study comparing two fixed daily doses (150 IU versus 225 IU) of recombinant FSH for ovarian stimulation during in-vitro fertilisation treatment in predicted low and intermediate responders based on antral follicle count on 3D ultrasound - Randomised study of 150 IU versus 225 IU of rFSH in non-PCO wome
- Conditions
- Infertility needing In-Vitro fertilisation treatment
- Registration Number
- EUCTR2006-001143-59-GB
- Lead Sponsor
- School of Human Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 184
--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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;<br> Primary end point(s): -Ongoing pregnancy rates<br> -Number of mature oocytes retreived<br> ;<br> 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.<br>
- Secondary Outcome Measures
Name Time Method