INtensity of OVarian Stimualtion and Euploid Embryos
- Conditions
- Fertility
- Interventions
- Drug: Follitropin-delta (Rekovelle) 20 mcg/day from D1Drug: Follitropin-delta (Rekovelle) 15 mcg/day from D1
- Registration Number
- NCT06154083
- Lead Sponsor
- FundaciĆ³n Santiago Dexeus Font
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 110
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Follitropin-delta 20 mcg/day from D1 Follitropin-delta (Rekovelle) 20 mcg/day from D1 - Follitropin-delta 15 mcg/day from D1 Follitropin-delta (Rekovelle) 15 mcg/day from D1 -
- Primary Outcome Measures
Name Time Method Number of euploid embryos Trough study completion, an average of 20-30 days. Number of euploid embryos
- Secondary Outcome Measures
Name Time Method Gonadotropin dose Up to oocyte pickup, an average of 10-20 days Total gonadotropin dose used
Estradiol Up to oocyte pickup, an average of 10-20 days Estradiol level
Length of stimulation Up to oocyte pickup, an average of 10-20 days Days of stimulation
Progesterone Up to oocyte pickup, an average of 10-20 days Progesterone level
Total number of embryos 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
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
Time of morula (tM) 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 Blastocyst formation rate Until 5, 6 or 7 days after insemination proportion of 2PN zygotes that reach the blastocyst stage
Ongoing pregnancy rate 8-10 weeks after transfer defined as a viable intrauterine pregnancy
Cycle cancelation rate Up to oocyte pickup, an average of 10-20 days Cycle cancelation 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 compactation (tSC) Until 3, or 4 days after insemination Time of full blastulation (tB) Until 4 or 7 days after insemination Number of embryos cryopreserved Until 5, 6 or 7 days after insemination Fertilization rate Up to one day after oocyte pickup, an average of 10-20 days Fertilization rate
Time of cavitation (tSB) Until 4 or 7 days after insemination 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 Embryo stage Until 5, 6 or 7 days after insemination
Trial Locations
- Locations (1)
Hospital Universitario Quiron Dexeus
šŖšøBarcelona, Spain