The impact of ovarian stimulation with hMG on embryo quality in advanced age women. A randomized controlled trial

2025-524761-25-00 Protocol FSD-QUA-2025-27 Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 4 sites · Protocol FSD-QUA-2025-27

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 240
Countries 1
Sites 4

infertility

To compare the number of good quality blastocysts based on the Istanbul consensus workshop criteria (Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Hum Reprod 2011) in two stimulation groups with 10 mcg/day of follitropin delta (equivalent to 150 IU of rFSH) + 150 IU/day of hMG vs 5 mcg/day of fol…

Key facts

Sponsor
Santiago Dexeus Font Fundacio Privada
Participant type
Patients
Age range
18-64 years
Gender
Female
Therapeutic area
Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Decision date (initial)
2026-06-23
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
Ferring

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To compare the number of good quality blastocysts based on the Istanbul consensus workshop criteria (Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Hum Reprod 2011) in two stimulation groups with 10 mcg/day of follitropin delta (equivalent to 150 IU of rFSH) + 150 IU/day of hMG vs 5 mcg/day of follitropin delta (equivalent to 75 IU of rFSH) + 225 IU/day of hMG in advanced age women undergoing PGT-A with a PPOS protocol.

Secondary objectives 28

  1. Total gonadotropin dose
  2. Length of stimulation
  3. Number of oocytes retrieved
  4. Number mature oocytes (MIIs) retrieved
  5. Endocrine profile at specific intervals (estradiol, progesterone, FSH and LH)
  6. Follicle to Oocyte Index (FOI) (ratio between the total number of oocytes collected at the end of ovarian stimulation and the number of antral follicles available at the start of stimulation).
  7. Follicular Output RaTe (FORT) (ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation).
  8. Cycle cancelation rate
  9. Reason for cycle cancelation
  10. Fertilization rate
  11. Time of appearance of the 2nd polar body (tPB2
  12. Time of pronuclei appearance (tPNa)
  13. Evaluation of both pronuclei (PN)
  14. Time of pronuclei disappearance (tPNf)
  15. Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8)
  16. Time of compaction (tSC)
  17. Time of morula (tM)
  18. Time of cavitation (tSB)
  19. Time of full blastulation (tB)
  20. Total number of day 5 blastocysts
  21. Total number of euploid embryos
  22. MII to Blastocyst formation rate, defined as the proportion of MII oocytes that reach the blastocyst stage
  23. Number of embryos cryopreserved
  24. Embryo stage (D5, D6, D7)
  25. Clinical pregnancy rate, defined as the visualization of one or more gestational sacs
  26. Ongoing pregnancy rate, defined as a viable intrauterine pregnancy of at least 8-10 weeks duration confirmed on an ultrasound scan
  27. Miscarriage rate
  28. Live birth rate

Conditions and MedDRA coding

infertility

VersionLevelCodeTermSystem organ class
27.1 PT 10021926 Infertility 100000004872
20.0 PT 10021928 Infertility female 100000004872

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Infertile patients with indication for IVF
  2. Undergoing preimplantation genetic screening cycles
  3. Age ≥38 and <42 years old
  4. AMH 0.5 – 3.5 ng/ml or AFC 5-20 (results of up to one year will be valid)
  5. BMI 18.5 – 30 Kg/m2
  6. Normal karyotypes in both partners

Exclusion criteria 8

  1. Previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol), according to Bologna criteria
  2. Severe male factor requiring TESE (testicular sperm extraction)
  3. Administration of any other drug potentially interfering with the treatment
  4. Contraindication for hormonal treatment
  5. Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment)
  6. Monogenic disease to be detected with PGT-M
  7. Biochemical and/or ultrasonographic evidence of polycystic ovarian syndrome
  8. Endocrinological and/or autoimmune disorders

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. To compare the two stimulation groups of 10 mcg/day of Follitropin delta + 150 IU hMG vs 5 mcg/day of Follitropin delta + 225 IU hMG regarding the embryo quality in advanced age women undergoing ovarian stimulation with a PPOS protocol.
  2. Fertilization rate

Secondary endpoints 28

  1. Total gonadotropin dose
  2. length of stimulation
  3. Number of oocytes retrieved
  4. Number mature oocytes (MIIs) retrieved
  5. Endocrine profile at specific intervals (estradiol, progesterone, FSH and LH)
  6. Follicle to Oocyte Index (FOI) (ratio between the total number of oocytes collected at the end of ovarian stimulation and the number of antral follicles available at the start of stimulation).
  7. Follicular Output RaTe (FORT) (ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation).
  8. Cycle cancelation rate
  9. Reason for cycle cancelation
  10. Fertilization rate
  11. Time of appearance of the 2nd polar body (tPB2)
  12. Time of pronuclei appearance (tPNa)
  13. Evaluation of both pronuclei (PN)
  14. Time of pronuclei disappearance (tPNf)
  15. Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8)
  16. Time of compaction. (tSC)
  17. Time of morula (tM)
  18. Time of cavitation (tSB)
  19. Time of full blastulation (tB)
  20. Total number of day 5 blastocysts
  21. Total number of euploid embryos
  22. MII to Blastocyst formation rate, defined as the proportion of MII oocytes that reach the blastocyst stage
  23. Number of embryos cryopreserved
  24. Embryo stage (D5, D6, D7)
  25. Clinical pregnancy rate, defined as the visualization of one or more gestational sacs
  26. Ongoing pregnancy rate, defined as a viable intrauterine pregnancy of at least 8-10 weeks duration confirmed on an ultrasound scan
  27. Miscarriage rate
  28. Live birth rate

Investigational products

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

Test 2

MENOPUR 600 UI polvo y disolvente para solución inyectable.

PRD474678 · Product

Active substance
Menotrophin
Substance synonyms
MENOTROPIN, MENOTROPIINI, MENOTROPINS
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
225 IU international unit(s)
Max total dose
3375 IU international unit(s)
Max treatment duration
15 Day(s)
Authorisation status
Authorised
ATC code
G03GA02 — HUMAN MENOPAUSAL GONADOTROPHIN
Marketing authorisation
73.585
MA holder
FERRING S.A.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen

PRD5098780 · Product

Active substance
Follitropin Delta
Substance synonyms
RFSH
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
10 µg microgram(s)
Max total dose
150 µg microgram(s)
Max treatment duration
15 Day(s)
Authorisation status
Authorised
ATC code
G03GA10 — -
Marketing authorisation
EU/1/16/1150/006
MA holder
FERRING PHARMACEUTICALS A/S
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 3

Seidigestan 200 mg cápsulas blandas

PRD308331 · Product

Active substance
Progesterone
Pharmaceutical form
CAPSULE, SOFT
Route of administration
ORAL
Max daily dose
200 IU international unit(s)
Max total dose
2250 IU international unit(s)
Max treatment duration
15 Day(s)
Authorisation status
Authorised
ATC code
G03DA04 — PROGESTERONE
Marketing authorisation
64.899
MA holder
SEID, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable

PRD390680 · Product

Active substance
Triptorelin
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
0.2 mg milligram(s)
Max total dose
0.2 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L02AE04 — TRIPTORELIN
Marketing authorisation
62.431
MA holder
IPSEN PHARMA S.A.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Utrogestan 200 mg cápsulas vaginales blandas

PRD10354307 · Product

Active substance
Progesterone
Pharmaceutical form
VAGINAL CAPSULE, SOFT
Route of administration
ORAL
Max daily dose
200 mg milligram(s)
Max total dose
3000 mg milligram(s)
Max treatment duration
15 Day(s)
Authorisation status
Authorised
ATC code
G03DA04 — PROGESTERONE
Marketing authorisation
88298
MA holder
BESINS HEALTHCARE IRELAND LIMITED
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Santiago Dexeus Font Fundacio Privada

9 Total trials 5 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Santiago Dexeus Font Fundacio Privada
Address
Gran Via De Carles III 71-75
City
Barcelona
Postcode
08028
Country
Spain

Scientific contact point

Organisation
Santiago Dexeus Font Fundacio Privada
Contact name
Ignacio Rodríguez

Public contact point

Organisation
Santiago Dexeus Font Fundacio Privada
Contact name
Ignacio Rodríguez

Locations

1 EU/EEA country · 4 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Authorised, recruitment pending 240 4
Rest of world — 0 —

Investigational sites

Spain

4 sites · Authorised, recruitment pending
Hospital Quironsalud Del Valles
Department of Reproductive Medicine, Passeig Rubio I Ors 25-27, 08203, Sabadell
Hospital Universitari General De Catalunya
Department of Reproductive Medicine, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Dexeus Mujer Tarragona
Department of Reproductive Medicine, Av. Josep Maria Recasens, SN, Tarragona
Hospital Universitari Dexeus Grupo Quironsalud
Department of Reproductive Medicine, Calle De Sabino Arana 5-19, 08028, Barcelona

Results and documents

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

Documents 22 files

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

TypeTitleVersion
Protocol (for publication) D1_EQUAM Study_Protocol 2
Recruitment arrangements (for publication) EQUAM-Post-Cast 1
Recruitment arrangements (for publication) EQUAM-Post-Cat 1
Recruitment arrangements (for publication) EQUAM-Story-Cast_1 1
Recruitment arrangements (for publication) EQUAM-Story-Cast_2 1
Recruitment arrangements (for publication) EQUAM-Story-Cast_3 1
Recruitment arrangements (for publication) EQUAM-Story-Cast_4 1
Recruitment arrangements (for publication) EQUAM-Story-Cat_ 1
Recruitment arrangements (for publication) EQUAM-Story-Cat_2 1
Recruitment arrangements (for publication) EQUAM-Story-Cat_3 1
Recruitment arrangements (for publication) EQUAM-Story-Cat_4 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) Mailing EQUAM_CA 1
Recruitment arrangements (for publication) Mailing EQUAM_ES 1
Recruitment arrangements (for publication) web EQUAM CAT 1
Recruitment arrangements (for publication) web EQUAM_ES 1
Subject information and informed consent form (for publication) L1_HIPCI_EQUAM V1_09012026 1
Subject information and informed consent form (for publication) L1_HIPCI_EQUAM V2_20052026 2
Summary of Product Characteristics (SmPC) (for publication) G2 FT Menopur 600_1200 1
Summary of Product Characteristics (SmPC) (for publication) G2 FT_rekovelle 1
Synopsis of the protocol (for publication) D1_Summary EQUAM_EN 1
Synopsis of the protocol (for publication) D1_Summary EQUAM_ES 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-03-10 Spain Acceptable
2026-06-19
 2026-06-23

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