Trial · Interventional

Status unknownPhase 4Registry data

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.

Short name PPDUO

NCTNCT06637189Other id2306-GFMAD-129-CBOther id2023-508769-33Other id2023

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 144 participants (estimated)
Sponsor: Ginefiv · Other
Design: Randomized · Open label (no masking)
Countries: Not stated
Start: 15 Oct 2024 (estimated)
Primary completion: 15 Jun 2025 (estimated)
Completion: 31 Dec 2025 (estimated)
First posted: 15 Oct 2024
Last update posted: 15 Oct 2024
Conditions: Stimulation in the Ovary · Embryo · Oocyte · Oocyte Retrieval · Fertilization in Vitro · Blastocyst · PGT-A

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

Ph 4
PPDUO
NCT06637189
est. 15 Oct 2024 to est. 31 Dec 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

GanirelixDrug
Medroxyprogesterone Acetate 10 MGDrug

Arms2

Experimental
PPOS - study group
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
Active comparator
GnRH antagonists - control group
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

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Euploid Embryos
Time frame · From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Registry description
Total number of euploid embryos after the two egg retrievals

Secondary outcomes(4)

Number of Oocytes retrieved
Time frame · From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Registry description
Total number of oocytes retrieved after the two egg retrievals
Number of Metaphase II oovcytes
Time frame · From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Registry description
Total number of metaphase II oocytes retrieved after the two egg retrievals
Number of Fertilized Oovytes
Time frame · From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Registry description
Total number of fertilized oocytes after the two egg retrievals
Number of Blastocysts
Time frame · From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Registry description
Total number of blastocyst stage embryos after the two egg retrievals

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2021

8 results

Medroxyprogesterone acetate is a useful alternative to a gonadotropin-releasing hormone antagonist in oocyte donation: a randomized, controlled trial.

Giles et al. 2021Fertility and sterilitycited by 52

PMID 33814126DOI 10.1016/j.fertnstert.2021.02.036PUB-33814126

Full text at the publisher8 results

Publisher page See results (8)

Indexing hint: Randomized controlled trial · 2019

9 results

Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial.

Beguería et al. 2019Human reproduction (Oxford, England)cited by 80

PMID 30927417DOI 10.1093/humrep/dez034PUB-30927417

Full text at the publisher9 results

Publisher page See results (9)

More studies

1 study on this page

PubMed tag: none · 2019

Desogestrel versus antagonist injections for LH suppression in oocyte donation cycles: a crossover study.

Martínez et al. 2019Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinologycited by 4

PMID 31062995DOI 10.1080/09513590.2019.1604661PUB-31062995

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 43 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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