A Phase 4 interventional study of Ganirelix and Medroxyprogesterone Acetate 10 MG in Stimulation in the Ovary, Embryo and Oocyte, sponsored by Ginefiv. Not yet recruiting. Open to female participants aged 18 Years to 43 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Ginefiv · Phase 4, Interventional, and Treatment
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.
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.
Ginefiv is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Patients belonging to this arm will initiate controlled ovarian stimulation by administering FSHr gonadotropin at doses between 225 IU-300 IU/day (according to patient characteristics) + 10mg medroxyprogesterone/day (IMP) from day 2-3 of their menstrual cycle. Both groups will continue with the usual regimen of administration of all medications related to Ovarian Stimulation
Drug: Medroxyprogesterone Acetate 10 MG
Patients belonging to this arm will initiate controlled ovarian stimulation by administering FSHr gonadotropin at doses between 225 IU-300 IU/day (according to patient characteristics) from day 2-3 of their menstrual cycle, and treatment with the 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 14mm is present. Both groups will continue with the usual regimen of administration of all medications related to Ovarian Stimulation
Drug: Ganirelix
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.
Number of Euploid Embryos
Total number of euploid embryos after the two egg retrievals
Time frame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Number of Oocytes retrieved
Total number of oocytes retrieved after the two egg retrievals
Time frame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Number of Metaphase II oovcytes
Total number of metaphase II oocytes retrieved after the two egg retrievals
Time frame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Number of Fertilized Oovytes
Total number of fertilized oocytes after the two egg retrievals
Time frame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Number of Blastocysts
Total number of blastocyst stage embryos after the two egg retrievals
Time frame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Oct 2024; primary completion for Jun 2025, 8 months later.
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This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Medroxyprogesterone Acetate