Infertility
Conditions
Keywords
ovarian stimulation, climiphene citrate, Gonadotropin-Releasing Hormone agonists/antagonists, Follicle Stimulating Hormone
Brief summary
The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF.
Interventions
PROCEDUREmild ovarian stimulation
100-150 mg of clomiphene citrate from day 2 till day 6 of the cycle and 150 mg of gonadotrophins as soon as 1 follicle is more than 14mm together with 1 fixed dose of GnRH antagonist until egg recovery
PROCEDUREconventional ovarian stimulation
300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses with GnRH agonist long protocol
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* poor responders (age\>40, previous POR, abnormal OR test) * indication for IVF * regular cycling patients * BMI 19-35
Exclusion criteria
* contraindication for clomiphene citrate use or to GnRH agonists antagonists * BMI \> 35
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of oocytes (COCs) | at oocyte recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy rate | 6 weeks | Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention |
| live birth | more than 20 weeks | — |
| Number/rate of participants whom the IVF cycle was cancelled | After the 1st week of ovarian stimulation, no oocytes at OR | — |
| stimulation characteristics | from start of stimulation until embryo transfer | total dose of gonadotropins administered, |
| cancellation rate | from start of stimulation until ET | when premature ovulation was evident by the loss of follicle(s) prior to oocyte recovery, and in cases where there were no oocytes retrieved or no embryos produced for transfer and in failed fertilization |
| miscarriage | pregnancy loss before 20 weeks of gestation, after a positive pregnancy test | — |
Countries
Greece
Outcome results
None listed