Fertility
Conditions
Brief summary
This randomized trial was designed as a no-inferiority trial aiming to evaluate if the intensity of stimulation (a milder vs a more intense approach) may have an impact on the number of euploid embryos and the morpho kinetic parameters in advanced age women undergoing PGT-A with a PPOS protocol.
Interventions
DRUGFollitropin-delta (Rekovelle) 20 mcg/day from D1
On day 2 or 3 of the menstrual cycle, daily injections of 20 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
DRUGFollitropin-delta (Rekovelle) 15 mcg/day from D1
On day 2 or 3 of the menstrual cycle, daily injections of 15 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls and blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
Sponsors
Fundación Santiago Dexeus Font
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
38 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Infertile patients with indication for IVF * Undergoing preimplantation genetic screening cycles * AMH \>= 1.5 ng/ml and \< 3.5 ng/ml (AMH result of up to one year will be valid) * BMI 18.5 - 30 Kg/m2
Exclusion criteria
* Severe male factor requiring TESE (testicular sperm extraction) * AMH \< 1.5 ng/ml or \>= 3.5 ng/ml * Administration of any other drug potentially interfering with the treatment * Contraindication for hormonal treatment * Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment). * Monogenic disease to be detected with PGT-M
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of euploid embryos | Trough study completion, an average of 20-30 days. | Number of euploid embryos |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gonadotropin dose | Up to oocyte pickup, an average of 10-20 days | Total gonadotropin dose used |
| Length of stimulation | Up to oocyte pickup, an average of 10-20 days | Days of stimulation |
| Estradiol | Up to oocyte pickup, an average of 10-20 days | Estradiol level |
| Progesterone | Up to oocyte pickup, an average of 10-20 days | Progesterone level |
| LH | Up to oocyte pickup, an average of 10-20 days | LH level |
| Follicular Output RaTe (FORT) | Day one of stimulation. 1 Day | ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation |
| Cycle cancelation rate | Up to oocyte pickup, an average of 10-20 days | Cycle cancelation rate |
| Fertilization rate | Up to one day after oocyte pickup, an average of 10-20 days | Fertilization rate |
| Time of appearance of the 2nd polar body (tPB2) | Up to one day after oocyte pickup, an average of 10-20 days | Time of appearance of the 2nd polar body (tPB2) |
| Time of pronuclei disappearance (tPNf) | Up to one day after oocyte pickup, an average of 10-20 days | — |
| Time of division from 2 to 8 cells | Until 1, or 4 days after insemination | — |
| Time of compactation (tSC) | Until 3, or 4 days after insemination | — |
| Time of morula (tM) | Until 4 or 7 days after insemination | — |
| Time of cavitation (tSB) | Until 4 or 7 days after insemination | — |
| Time of full blastulation (tB) | Until 4 or 7 days after insemination | — |
| Total number of day 5 blastocysts | Until 5, 6 or 7 days after insemination | — |
| Total number of good quality blastocysts | Until 5, 6 or 7 days after insemination | — |
| Total number of embryos | Until 5, 6 or 7 days after insemination | — |
| Blastocyst formation rate | Until 5, 6 or 7 days after insemination | proportion of 2PN zygotes that reach the blastocyst stage |
| Number of embryos cryopreserved | Until 5, 6 or 7 days after insemination | — |
| Embryo stage | Until 5, 6 or 7 days after insemination | — |
| Clinical pregnancy rate | 5-6 weeks after transfer | defined as the visualization of one or more gestational sacs |
| Ongoing pregnancy rate | 8-10 weeks after transfer | defined as a viable intrauterine pregnancy |
Countries
Spain
Contacts
CONTACTNikolaos P Polyzos, MD, PhD
CONTACTIgnacio Rodríguez, MSc
Outcome results
None listed