Embryo QUAlity in Ovarian Stimulation With hMG. (EQUAM)

July 1, 2026 updated by: Fundacion Dexeus

The Impact of Ovarian Stimulation With hMG on Embryo Quality in Advanced Age Women. A Randomized Controlled Trial

Ovarian stimulation (OS) is a key component of IVF, aimed at increasing oocyte yield and improving embryo development potential. While early protocols relied solely on FSH, newer approaches incorporate hMG and LH-based stimulation, allowing more individualized treatments for specific patient populations. Evidence suggests that hMG and recombinant FSH (rFSH) have comparable effectiveness in stimulation outcomes, and current guidelines support the use of both. However, the impact of different gonadotropins on embryo quality remains unclear, with mixed findings across protocols. Given the increasing use of combined rFSH and hMG and the limited data in PPOS protocols, this study proposes a randomized controlled trial to compare embryo quality between two different rFSH-hMG dosing strategies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ignacio Rodriguez, MSc
  • Phone Number: 22029 0034932274700
  • Email: nacrod@dexeus.com

Study Locations

  • Spain
      • Barcelona, Spain, 08037
        • Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
        • Contact:
        • Principal Investigator:
          • Nikolaos P Polyzos, MD PhD
        • Sub-Investigator:
          • Valeria Donno, MD
        • Sub-Investigator:
          • Marta Plancha,, MD
      • Tarragona, Spain, 43206
        • Dexeus Mujer Tarragona
        • Contact:
          • Josep Gonzalo, MD
        • Sub-Investigator:
          • Josep Gonzalo, MD
    • Barcelona
      • Sabadell, Barcelona, Spain, 08203
        • Dexeus Mujer Sabadell
        • Contact:
        • Sub-Investigator:
          • Ainhoa Coco, MD
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Dexeus Mujer Sant Cugat
        • Contact:
        • Sub-Investigator:
          • Ainhoa Coco, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing preimplantation genetic screening cycles
  • AMH 0.5 - 3.5 ng/ml or AFC 5-20 (results of up to one year will be valid)
  • BMI 18.5 - 30 Kg/m2
  • Normal karyotypes in both partners

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 mcg of Rekovelle + 150 IU of Menopur
On day 2 or 3 of the menstrual cycle, daily injections of 10 mcg of Rekovelle + 150 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
Drug: 10 mcg of follitropin-delta + 150 of hMG
On day 2 or 3 of the menstrual cycle, daily injections of 10 mcg of Rekovelle + 150 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
Active Comparator: 5 mcg of Rekovelle + 225 IU of Menopur
On day 2 or 3 of the menstrual cycle, daily injections of 5 mcg of Rekovelle + 225 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
Drug: 5 mcg of follitropin-delta + 225 of hMG
On day 2 or 3 of the menstrual cycle, daily injections of 5 mcg of Rekovelle + 225 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Good quality blastocysts
Time Frame: From Day 5 to Day 7 after insemination
number of good quality blastocysts based on the Istanbul consensus workshop criteria
From Day 5 to Day 7 after insemination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Gonadotropin Dose Administered
Time Frame: From initiation of ovarian stimulation until day of trigger (up to 15 days)
Cumulative dose of gonadotropins (IU) administered during ovarian stimulation.
From initiation of ovarian stimulation until day of trigger (up to 15 days)
Duration of Ovarian Stimulation
Time Frame: From first day of stimulation until trigger day (up to 15days)
Number of days of gonadotropin administration required to reach criteria for triggering final oocyte maturation.
From first day of stimulation until trigger day (up to 15days)
Total Number of Oocytes Retrieved
Time Frame: At oocyte retrieval
Total number of oocytes collected during oocyte retrieval procedure following ovarian stimulation.
At oocyte retrieval
Number of mature oocytes (MII) retrieved
Time Frame: At oocyte retrieval
Number of metaphase II (MII) oocytes identified among retrieved oocytes
At oocyte retrieval
Serum levels of estradiol (E2)
Time Frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of estradiol (E2) measured at predefined time points during stimulation
At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of progesterone (P4)
Time Frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels progesterone (P4) measured at predefined time points during stimulation
At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of follicle-stimulating hormone (FSH)
Time Frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels follicle-stimulating hormone (FSH) measured at predefined time points during stimulation
At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of luteinizing hormone (LH)
Time Frame: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels luteinizing hormone (LH) measured at predefined time points during stimulation
At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Follicle-to-Oocyte Index (FOI)
Time Frame: From baseline AFC assessment to oocyte retrieval
Ratio between the total number of oocytes retrieved and the number of antral follicles counted at baseline before stimulation.
From baseline AFC assessment to oocyte retrieval
Follicular Output RaTe (FORT)
Time Frame: From baseline AFC assessment to trigger day
Ratio between the number of preovulatory follicles on the day of trigger and the number of antral follicles at baseline.
From baseline AFC assessment to trigger day
Cycle cancellation rate
Time Frame: From start of stimulation to planned oocyte retrieval
Proportion of initiated ovarian stimulation cycles that are cancelled before oocyte retrieval.
From start of stimulation to planned oocyte retrieval
Reason for cycle cancellation
Time Frame: At time of cycle cancellation
Categorization of causes leading to cycle cancellation (e.g., poor response, hyper-response/risk of OHSS, premature ovulation, patient decision, or medical reasons).
At time of cycle cancellation
Fertilization Rate
Time Frame: Assessed 16-20 hours post-insemination or ICSI
Proportion of oocytes that are successfully fertilized (2PN) relative to the number of inseminated or injected (ICSI) oocytes.
Assessed 16-20 hours post-insemination or ICSI
Time of appearance of the 2nd polar body (tPB2)
Time Frame: Within 0-6 hours post-ICSI/insemination
ime from insemination or ICSI to the extrusion of the second polar body, indicating completion of oocyte activation.
Within 0-6 hours post-ICSI/insemination
Time of pronuclei appearance (tPNa)
Time Frame: Within 0-20 hours post-ICSI/insemination
Time from insemination or ICSI to the first visualization of pronuclei.
Within 0-20 hours post-ICSI/insemination
Evaluation of both pronuclei
Time Frame: Within 0-20 hours post-ICSI/insemination
Time from insemination or ICSI to the visualization of both pronuclei.
Within 0-20 hours post-ICSI/insemination
Time to Pronuclear Fading (tPNf)
Time Frame: Within 20-30 hours post-ICSI/insemination
Time from insemination or ICSI to disappearance of pronuclei
Within 20-30 hours post-ICSI/insemination
Timing of Early Cleavage Stages (t2-t8)
Time Frame: From fertilization to Day 3 (up to 72 hours)
Time to reach each embryonic cell stage from 2 to 8 cells
From fertilization to Day 3 (up to 72 hours)
Time of compaction (tSC)
Time Frame: Day 3-4 post-fertilization (up to ~96 hours)
Time from fertilization to the beginning of blastomere compaction.
Day 3-4 post-fertilization (up to ~96 hours)
Time of morula (tM)
Time Frame: Day 4 post-fertilization (up to 120 hours)
Time from fertilization to the formation of a compact morula stage embryo.
Day 4 post-fertilization (up to 120 hours)
Time of cavitation (tSB)
Time Frame: Day 4-5 post-fertilization (up to ~120-132 hours)
Time from fertilization to the initiation of blastocoel cavity formation.
Day 4-5 post-fertilization (up to ~120-132 hours)
Time of full blastulation (tB)
Time Frame: Day 5-6 post-fertilization (up to ~144 hours)
Time from fertilization to formation of a fully expanded blastocyst.
Day 5-6 post-fertilization (up to ~144 hours)
Total number of Day 5 blastocysts
Time Frame: Day 5 post-fertilization
Number of embryos reaching the blastocyst stage by Day 5 of development.
Day 5 post-fertilization
Total number of Day 6 blastocysts
Time Frame: Day 5 post-fertilization
Number of embryos reaching the blastocyst stage by Day 6 of development.
Day 5 post-fertilization
Total number of Day 7 blastocysts
Time Frame: Day 5 post-fertilization
Number of embryos reaching the blastocyst stage by Day 7 of development.
Day 5 post-fertilization
Total number of euploid embryos
Time Frame: After genetic testing results (typically within 1-2 weeks post-biopsy)
Number of embryos identified as chromosomally normal following preimplantation genetic testing (PGT-A)
After genetic testing results (typically within 1-2 weeks post-biopsy)
MII to blastocyst formation rate
Time Frame: From oocyte retrieval to blastocyst stage (up to Day 5-7)
Proportion of mature (MII) oocytes that develop into blastocysts.
From oocyte retrieval to blastocyst stage (up to Day 5-7)
Number of embryos cryopreserved
Time Frame: At end of embryo culture (Day 5-7)
Total number of embryos suitable for vitrification following culture.
At end of embryo culture (Day 5-7)
Clinical pregnancy rate
Time Frame: At 5-7 weeks of gestation
Presence of one or more intrauterine gestational sacs confirmed by ultrasound.
At 5-7 weeks of gestation
Ongoing Pregnancy Rate
Time Frame: At 8-10 weeks of gestation
Proportion of pregnancies with a viable intrauterine fetus beyond 8-10 weeks of gestation confirmed by ultrasound.
At 8-10 weeks of gestation
Miscarriage Rate
Time Frame: From confirmation of clinical pregnancy up to 20 weeks of gestation
Proportion of clinical pregnancies that result in spontaneous pregnancy loss before 20 weeks of gestation.
From confirmation of clinical pregnancy up to 20 weeks of gestation
Live birth rate
Time Frame: At delivery (up to ~40 weeks of gestation following embryo transfer)
Proportion of embryo transfer cycles resulting in at least one live-born infant, defined as the delivery of a living neonate after ≥24 weeks of gestation.
At delivery (up to ~40 weeks of gestation following embryo transfer)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Dexeus

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Nikolaos P Polyzos, MD, PhD, Dexeus Universitary Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSD-QUA-2025-27
  • 2025-524761-25-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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