Clinical trial NCT06637189: Protocol with Progestin-primed Ovarian Stimulation (PPOS) from the Beginning of Stimulation Versus Protocol with GnRH Antagonists for Ovarian Stimulation in Patients Undergoing DUOSTIM with Embryo Accumulation for PGT-A.
Official title: Protocol with Progestin-primed Ovarian Stimulation (PPOS) from the Beginning of Stimulation Versus Protocol with GnRH Antagonists for Ovarian Stimulation in Patients Undergoing DUOSTIM with Embryo Accumulation for PGT-A.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Stimulation in the Ovary
Embryo
Oocyte
Oocyte Retrieval
Fertilization in Vitro
Blastocyst
PGT-A
Keywords: duostim
ovarian stimulation
progesterone
GnRH antagonists
PGT-A
Lead sponsor: Ginefiv
Sponsor class: OTHER
Collaborators: name: Theramex
First posted: 2024-10-15
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Euploid Embryos
timeFrame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Secondary outcomes:
measure: Number of Oocytes retrieved
timeFrame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
measure: Number of Metaphase II oovcytes
timeFrame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
measure: Number of Fertilized Oovytes
timeFrame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
measure: Number of Blastocysts
timeFrame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.