Protocol with Progestin-primed Ovarian Stimulation (PPOS) in conventional treatment from the start of stimulation vs protocol with GnRH antagonists as a pituitary suppressor in patients who are going to undergo DUOSTIM with embryo accumulation for PGT-A of the embryos.

2023-508769-33-00 Therapeutic use (Phase IV) Ongoing, recruiting

Start 5 Dec 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 144
Countries 1
Sites 2

Female infertility

To study whether there is a difference in the number of euploid embryos obtained in two groups of patients who are going to accumulate embryos for PGT-A by means of double ovarian stimulation, comparing two methods of pituitary suppression: the use of gestagens from the beginning of stimulation and the use of GnRH anta…

Key facts

Sponsor
Ginefiv S.L.
Participant type
Patients
Age range
18-64 years
Gender
Female
Therapeutic area
Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration
5 Dec 2024 → ongoing
Decision date (initial)
2024-03-11
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
Theramex

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To study whether there is a difference in the number of euploid embryos obtained in two groups of patients who are going to accumulate embryos for PGT-A by means of double ovarian stimulation, comparing two methods of pituitary suppression: the use of gestagens from the beginning of stimulation and the use of GnRH antagonists.

Conditions and MedDRA coding

Female infertility

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. 1. Age less than 43 years . 2. Regular menstrual cycles between 21 and 35 days. 3. Indication for IVF with PGT-A 4. Both ovaries present. 5. Ability to participate and complete the study. 6. Give and sign consent to participate in the study.

Exclusion criteria 1

  1. 1. Endometriosis grade III/IV 2. Concurrent participation in another study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. number of euploid embryos

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Progevera 10 mg comprimidos

PRD499445 · Product

Active substance
Medroxyprogesterone Acetate
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
140 mg milligram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
G03DA02 — MEDROXYPROGESTERONE
Marketing authorisation
59.139
MA holder
PFIZER, S.L.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

Ganirelix

SUB07883MIG · Substance

Active substance
Ganirelix
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
0.25 mg milligram(s)
Max total dose
2.75 mg milligram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ginefiv S.L.

Sponsor organisation
Ginefiv S.L.
Address
Calle Jose Silva 18
City
Madrid
Postcode
28043
Country
Spain

Scientific contact point

Organisation
Ginefiv S.L.
Contact name
Claudia Blancafort

Public contact point

Organisation
Ginefiv S.L.
Contact name
Claudia Blancafort

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ongoing, recruiting 144 2
Rest of world — 0 —

Investigational sites

Spain

2 sites · Ongoing, recruiting
Ginefiv S.L.
Medicina Reproductiva, Gran Via de les Corts Catalanes, 456, Barcelona
Ginefiv S.L.
Medicina Reproductiva, Calle Jose Silva 18, 28043, Madrid

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2024-12-05 2024-12-06

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) 2306-GFMAD-129-CB PROTOCOLO_2023-508769-33-00_Redacted 1
Protocol (for publication) PROTOCOL_v2_20260127_Redacted_2306-GFMAD-129-CB 2
Recruitment arrangements (for publication) informedconsent_patientrecruitmentprocedure_2023-508769-33-00 1
Subject information and informed consent form (for publication) 2306-GFMAD-129-CB HIP_CI_2023-508769-33-00 1
Subject information and informed consent form (for publication) PIS_IC_2306-GFMAD-129-CB_v2_20260127_Redacted 2
Summary of Product Characteristics (SmPC) (for publication) FT Ganirelix_Astarte 1
Summary of Product Characteristics (SmPC) (for publication) FT Ganirelix_Orgalutran 1
Summary of Product Characteristics (SmPC) (for publication) FT Progevera 1
Synopsis of the protocol (for publication) 2306-GFMAD-129-CB_Synopsis_v2_27-01-2026 2

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-11-29 Spain Acceptable
2024-02-12
 2024-03-11
2 SUBSTANTIAL MODIFICATION SM-1 2026-02-10 Spain Acceptable
2026-05-18
 2026-05-25

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