Blastocyst, Embryo, Fertilization in Vitro, Oocyte, Oocyte Retrieval, PGT-A, Stimulation in the Ovary
Conditions
Keywords
duostim, ovarian stimulation, progesterone, GnRH antagonists, PGT-A
Brief summary
The PPOS protocol (Progestin-primed Ovarian Stimulation) involves avoiding ovulation during ovarian stimulation with progesterone. It is a reliable and safe protocol that has been widely used in recent years for in vitro fertilization, as it reduces the number of injections needed during controlled ovarian stimulation and is more cost-effective for patients. The aim of this study is to compare two methods of ovarian stimulation for in vitro fertilization: the PPOS protocol (Group A) and the conventional protocol with injected antagonists (Group B). The goal is to determine whether both methods are equally effective in obtaining euploid embryos in the context of double ovarian stimulation.
Detailed description
Hypothesis: Hypothesis: The number of euploid embryos obtained in a DUOSTIM cycle with PPOS is not inferior to that obtained with the use of antagonists. General and Specific Objectives Main Objective: To study if there is a difference in the number of euploid embryos obtained in two groups of patients undergoing embryo accumulation for PGT-A through double ovarian stimulation, comparing two methods of pituitary suppression: Progesterone use from the start of stimulation and the use of GnRH antagonists. Secondary Objectives: Evaluate if there are differences between both groups regarding the number of MII oocytes. Evaluate if there are differences between both groups regarding the number of cumulus-oocyte complexes (COC). Study the differences between both groups regarding the total consumption of gonadotropins. Evaluate if there are differences between both groups regarding the number of stimulation days. Evaluate if there are differences in fertilization rate after microinjection. Evaluate if there are differences between both groups regarding the cancellation rate. Evaluate if there are differences between both groups regarding the number of total embryos. Evaluate if there are differences between both groups regarding the number of embryos subjected to trophectoderm biopsy.
Interventions
DRUGGanirelix
Ganirelix is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitively binding to GnRH receptors in the pituitary gland. Consequently, there is a reversible, intense, and rapid suppression of endogenous gonadotropin release. Ganirelix is indicated for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproductive techniques (ART).
Medroxyprogesterone acetate is a synthetic progestin (structurally related to progesterone) with antiestrogenic, antiandrogenic, and antigonadotropic action. It inhibits pituitary gonadotropins (FSH and LH) with consequent inhibition of follicular maturation and ovulation . Medroxyprogesterone acetate is active orally and parenterally, 15 times more potent than progesterone. In addition to inhibiting ovulation, progestins also act on the endometrium preventing implantation and increasing the viscosity of cervical mucus, which hinders sperm progression in the uterus. It also transforms a proliferative endometrium into a secretory endometrium, provided that the woman has adequate endogenous estrogen levels.
Sponsors
Theramex
Ginefiv
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, randomized non-inferiority study. There will be two groups of patients: Patients in Group A (PPOS protocol - study group) will start controlled ovarian stimulation with the administration of FSHr gonadotropin at doses between 225 IU-300 IU/day (depending on patient characteristics) + 10 mg medroxyprogesterone/day (IMP). Patients in Group B (Short protocol with GnRH antagonists - control group) will start controlled ovarian stimulation with the administration of FSHr gonadotropin at doses between 225 IU-300 IU/day (depending on patient characteristics) and will add treatment with a GnRH antagonist at a dose of 0.25 mg/day from the 6th day of stimulation or when a follicle with a size equal to or greater than 14 mm is present. Once the two stimulations typical of the DuoStim strategy are completed, the results obtained in both groups will be compared.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes
Inclusion criteria
* Regular menstrual cycles between 21 and 35 days, inclusive. * Indication of IVF with PGT-A. * Both ovaries present. * Ability to participate and complete the study. * Give and sign the consent to participate in the study.
Exclusion criteria
* Endometriosis grade III/IV * Concurrent participation in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Euploid Embryos | From date of randomization until the end of the treatment. Assessed up to 12 weeks. | Total number of euploid embryos after the two egg retrievals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Oocytes retrieved | From date of randomization until the end of the treatment. Assessed up to 12 weeks. | Total number of oocytes retrieved after the two egg retrievals |
| Number of Metaphase II oovcytes | From date of randomization until the end of the treatment. Assessed up to 12 weeks. | Total number of metaphase II oocytes retrieved after the two egg retrievals |
| Number of Fertilized Oovytes | From date of randomization until the end of the treatment. Assessed up to 12 weeks. | Total number of fertilized oocytes after the two egg retrievals |
| Number of Blastocysts | From date of randomization until the end of the treatment. Assessed up to 12 weeks. | Total number of blastocyst stage embryos after the two egg retrievals |
Contacts
Primary ContactClaudia Blancafort González-Casabón, MD
Backup ContactJoaquín Llácer, phD
Outcome results
None listed