Infertility
Conditions
Brief summary
The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Reduction in the proportion of subjects with progesterone \> 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.
Detailed description
Each patient will receive a first visit for infertility where will be collected subject history and baseline information, and meet all the inclusion / exclusion criteria. Eligible patients who agreed to participate will be randomized to either long acting standard COS with corifollitropin alpha or standard COS with daily FSH in a fixed GnRH antagonist protocol. All patients will be allowed to participate in the study only once and a written informed consent will be obtained from all, following consultation and before the initiation of the treatment. The endocrine profile of all the patients will be evaluated by analysis of serum progesterone, 17b-estradiol (E2), FSH and LH at different time points: basal condition, during stimulation, at the hCG day and at pick-up. Transvaginal follicular aspiration will be performed by ultrasound guidance 36 hours after hCG administration. The day of pick up oocytes will be fertilized with partner's semen; after 3-5 days, on the base of its evolution, embryo will be transferred. 14 days after embryo-transfer a preg-nancy test will be performed. Follow up in case of obtained pregnancy will be done until 20 weeks of gestation and considered as ongoing pregnancy. The entire duration of the study is 24 months, the follow up of the last patients enrolled will be 6 months.
Interventions
DRUGCorifollitropin alfa
Controlled ovarian stimulation long-acting protocol
DRUGFollitropin Beta
Daily controlled ovarian stimulation protocol
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Indication to IVF treatment * Normal BMI (18.5-24.9 kg/m2) * AMH level \< 1.1 ng/ml and/or AFC \< 5 follicles and/or \< 3 oo-cytes retrieved in previous cycle * Regular menstrual cycles * Signed informed consent
Exclusion criteria
* Freeze all cycles for abnormal bleeding * PCOS * History of untreated autoimmune * Endocrine or metabolic disorders * Ovarian cystectomy or oophorectomy * FSH ≥ 20 lU/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Premature progesterone elevation | day 12 | Progesterone \> or equal to 1.1 ng/mL at day of trigger |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of oocytes collected at ovum retrieval | day 14 | — |
| Fertilization rate | day 15 | Percentage of oocytes fertilized |
| Percentage of freeze-all cycles due to premature progesterone elevation | day 12 | — |
| Pregnancy rate | day 30 | Beta-HCG positive |
| Ongoing pregnancy | Up to 20 weeks | Vital fetus at 20 weeks of gestation |
| Number of embryos available | Day 17 | — |
Countries
Italy
Outcome results
None listed