Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508769-33 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Theramex | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPOS - study group | Experimental | 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 |
|
| GnRH antagonists - control group | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganirelix | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Euploid Embryos | Total number of euploid embryos after the two egg retrievals | From date of randomization until the end of the treatment. Assessed up to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Oocytes retrieved | Total number of oocytes retrieved after the two egg retrievals | From date of randomization until the end of the treatment. Assessed up to 12 weeks. |
| Number of Metaphase II oovcytes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Blancafort González-Casabón, MD | Contact | +34647437121 | c.blancafort@ginefiv.com | |
| JoaquÃn Llácer, phD | Contact | j.llacer@gmail.com |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31062995 | Background | Martinez F, Rodriguez-Purata J, Beatriz Rodriguez D, Clua E, Rodriguez I, Coroleu B. Desogestrel versus antagonist injections for LH suppression in oocyte donation cycles: a crossover study. Gynecol Endocrinol. 2019 Oct;35(10):878-883. doi: 10.1080/09513590.2019.1604661. Epub 2019 May 7. | |
| 34867773 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| Medroxyprogesterone Acetate 10 MG | Drug | 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. |
|
Total number of metaphase II oocytes retrieved after the two egg retrievals
| 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 | 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 | From date of randomization until the end of the treatment. Assessed up to 12 weeks. |
| Dong M, Sun L, Huang L, Wang F, Zhang X, Liu F. Fixed Gonadotropin-Releasing Hormone Antagonist Protocol Versus Flexible Progestin-Primed Ovarian Stimulation Protocol in Patients With Asynchronous Follicular Development During Controlled Ovulation Stimulation: A Retrospective Study. Front Endocrinol (Lausanne). 2021 Nov 18;12:690575. doi: 10.3389/fendo.2021.690575. eCollection 2021. |
| 31209815 | Background | Xiao ZN, Peng JL, Yang J, Xu WM. Flexible GnRH Antagonist Protocol versus Progestin-primed Ovarian Stimulation (PPOS) Protocol in Patients with Polycystic Ovary Syndrome: Comparison of Clinical Outcomes and Ovarian Response. Curr Med Sci. 2019 Jun;39(3):431-436. doi: 10.1007/s11596-019-2055-x. Epub 2019 Jun 17. |
| 33814126 | Background | Giles J, Alama P, Gamiz P, Vidal C, Badia P, Pellicer A, Bosch E. Medroxyprogesterone acetate is a useful alternative to a gonadotropin-releasing hormone antagonist in oocyte donation: a randomized, controlled trial. Fertil Steril. 2021 Aug;116(2):404-412. doi: 10.1016/j.fertnstert.2021.02.036. Epub 2021 Apr 2. |
| 30927417 | Background | Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034. |
| 33268401 | Background | Wang N, Zhu Q, Ma M, Liang Z, Tao Y, Wang Y, Kuang Y. Comparison of a progestin-primed ovarian stimulation protocol with a flexible GnRH antagonist protocol in patients with polycystic ovary syndrome who are participating in an IVF programme: study protocol for a randomised controlled trial. BMJ Open. 2020 Dec 2;10(12):e038153. doi: 10.1136/bmjopen-2020-038153. |
| ID | Term |
|---|---|
| C061018 | ganirelix |
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided