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.

NCT06637189 | Not Yet Recruiting Phase 4

• 2 other identifiers: 2306-GFMAD-129-CB2023-508769-33
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/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.

Conditions

Stimulation in the Ovary; Embryo; Oocyte; Oocyte Retrieval; Fertilization in Vitro; Blastocyst; PGT-A

Keywords

duostim; ovarian stimulation; progesterone; GnRH antagonists; PGT-A

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Number of Oocytes retrieved

  From date of randomization until the end of the treatment. Assessed up to 12 weeks.

• Number of Metaphase II oovcytes

  From date of randomization until the end of the treatment. Assessed up to 12 weeks.

• Number of Fertilized Oovytes

  From date of randomization until the end of the treatment. Assessed up to 12 weeks.

• Number of Blastocysts

  From date of randomization until the end of the treatment. Assessed up to 12 weeks.

Study Arms (2)

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

Drug: Medroxyprogesterone Acetate 10 MG

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

Drug: Ganirelix

Interventions

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).

GnRH antagonists - control group

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.

PPOS - study group

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Endometriosis grade III/IV
• Concurrent participation in another study

Sponsors & Collaborators

• Ginefiv: lead
• Theramex: collaborator

Related Publications (6)

• 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.

  PMID: 31062995 BACKGROUND

• 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.

  PMID: 34867773 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.

  PMID: 31209815 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.

  PMID: 33814126 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.

  PMID: 30927417 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.

  PMID: 33268401 BACKGROUND

MeSH Terms

Interventions

ganirelix; Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Claudia Blancafort González-Casabón, MD

CONTACT

+34647437121; c.blancafort@ginefiv.com

Joaquín Llácer, phD

CONTACT

j.llacer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: December 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-09