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.

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-43
SponsorGinefiv

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Endometriosis grade III/IV

Concurrent participation in another study

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: PPOS - study groupExperimental treatment 1 intervention
Group B: GnRH antagonists - control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ginefiv

Lead sponsor

Theramex

Collaborator

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