AzTrials
AzTrials

Fertility IssuesPhase 4NCT05815719

Continuous Double Ovarian Stimulation.

A Phase 4 study testing Corifollitropin Alfa, Follitropin Alfa and Follitropin Alfa Biosimilar in people with Fertility Issues, run by Instituto Bernabeu at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the efficacy of the weekly use of corifollitropin alfa in double ovarian stimulation process and to compare it to the conventional protocol with daily medication administration. Read more about this study

Who is it for?
Ages 18 to 43 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fertility Issues
What is being tested?
Corifollitropin Alfa, Follitropin Alfa and Follitropin Alfa Biosimilar
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSpain
Study dates
17 Nov 2022to 30 May 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 43 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients with indication for DUOSTIM protocol
  • Maximum age of 43 years (up to one day before their 44th birthday) at the beginning of the stimulation process.
  • Ability to participate and comply with the study protocol.
  • To have given written consent

Who cannot join

  • Finding of ovarian pathology at the time of initiation of stimulation: e.g. ovarian cysts.
  • Concurrent participation in another study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Instituto Bernabeu

    Alicante, 03016

Other trials in Spain

About this study

Official title: Continuous Ovarian Stimulation in DUOSTIM Cycles.

To evaluate the efficacy of the weekly use of corifollitropin alfa in double ovarian stimulation process and to compare it to the conventional protocol with daily medication administration.

Read the detailed description

The purpose of this pilot study is to evaluate the efficacy of the weekly use of corifollitropin alfa in terms of ovarian stimulation results and its biological outcomes (total number of oocytes retrieved) in case of ovarian stimulation cycles in double stimulation modality (DUOSTIM) and in comparison with the conventional DUOSTIM protocol: daily administration of gonadotropins.

Being tested
Corifollitropin Alfa, Follitropin Alfa, Follitropin Alfa Biosimilar, Urinary Human follicle stimulating hormone
Keywords
OVARIAN STIMULATION
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Corifollitropin AlfaDrug

    Also called 4 Weekly Corifollitropin Alfa injections

    150 micrograms per dose

  • Follitropin AlfaDrug

    Also called Daily injections of gonadotropins

    Variable dose.

  • Follitropin Alfa BiosimilarDrug

    Also called Daily injections of gonadotropins

    Variable dose.

  • Urinary Human follicle stimulating hormoneDrug

    Also called Daily injections of gonadotropins

    Variable dose.

Study groups in NCT05815719
Study groupRoleWhat they receive
Study groupExperimentalPatients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.
Receives: Drug: Corifollitropin Alfa
Control groupActive comparatorPatients to carry out a conventional double ovarian stimulation and to receive daily injections of gonadotropins. Retrospective group (data retrieved from strictly selected treatments carried out in our institution within the 24 months prior to the inclusion of the first patient in the study group and according to the standard guideline of the clinic).
Receives: Drug: Follitropin Alfa; Drug: Follitropin Alfa Biosimilar; Drug: Urinary Human follicle stimulating hormone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Number of Retrieved Oocytes

    To investigate the total number of oocytes retrieved through ovarian stimulation in double ovarian stimulation cycles (DUOSTIM) utilizing weekly subcutaneous injections of Corifollitropin alfa (study group) vs. daily injections of gonadotropins (control group).

    Measured: Through study completion, an average of four weeks

  2. Number of MII Oocytes

    To compare the total number of MII oocytes obtained in double stimulation cycles in study vs control groups

    Measured: Through study completion, an average of four months

Secondary outcomes (2)

  1. Duration of Ovarian Stimulation

    Total days of follicular and luteal phases

    Measured: Through study completion, an average of four months

  2. Number of Injections

    Number of injections during the DUOSTIM cycle

    Measured: Through study completion, an average of four months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start17 Nov 2022
  3. Primary completion30 Apr 2023
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05815719
Sponsor's protocol ID
IBMR31
Other IDs
2022-003177-32
Status last verified
May 2025
First submitted
23 Mar 2023
Last updated
18 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The PI will collect individual data which will later be analyzed. Only analyzed overall data will be shared.

Publications

  • Baerwald AR, Adams GP, Pierson RA. Characterization of ovarian follicular wave dynamics in women. Biol Reprod. 2003 Sep;69(3):1023-31. doi: 10.1095/biolreprod.103.017772. Epub 2003 May 14.

    PubMed 12748128

  • Devroey P, Boostanfar R, Koper NP, Mannaerts BM, Ijzerman-Boon PC, Fauser BC; ENGAGE Investigators. A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod. 2009 Dec;24(12):3063-72. doi: 10.1093/humrep/dep291. Epub 2009 Aug 14.

    PubMed 19684043

  • Kuang Y, Chen Q, Hong Q, Lyu Q, Ai A, Fu Y, Shoham Z. Double stimulations during the follicular and luteal phases of poor responders in IVF/ICSI programmes (Shanghai protocol). Reprod Biomed Online. 2014 Dec;29(6):684-91. doi: 10.1016/j.rbmo.2014.08.009. Epub 2014 Sep 6.

    PubMed 25444501

  • Kuang Y, Hong Q, Chen Q, Lyu Q, Ai A, Fu Y, Shoham Z. Luteal-phase ovarian stimulation is feasible for producing competent oocytes in women undergoing in vitro fertilization/intracytoplasmic sperm injection treatment, with optimal pregnancy outcomes in frozen-thawed embryo transfer cycles. Fertil Steril. 2014 Jan;101(1):105-11. doi: 10.1016/j.fertnstert.2013.09.007. Epub 2013 Oct 23.

    PubMed 24161646

  • Vaiarelli A, Cimadomo D, Petriglia C, Conforti A, Alviggi C, Ubaldi N, Ledda S, Ferrero S, Rienzi L, Ubaldi FM. DuoStim - a reproducible strategy to obtain more oocytes and competent embryos in a short time-frame aimed at fertility preservation and IVF purposes. A systematic review. Ups J Med Sci. 2020 May;125(2):121-130. doi: 10.1080/03009734.2020.1734694. Epub 2020 Apr 25.

    PubMed 32338123

  • Vaiarelli A, Cimadomo D, Trabucco E, Vallefuoco R, Buffo L, Dusi L, Fiorini F, Barnocchi N, Bulletti FM, Rienzi L, Ubaldi FM. Double Stimulation in the Same Ovarian Cycle (DuoStim) to Maximize the Number of Oocytes Retrieved From Poor Prognosis Patients: A Multicenter Experience and SWOT Analysis. Front Endocrinol (Lausanne). 2018 Jun 14;9:317. doi: 10.3389/fendo.2018.00317. eCollection 2018.

    PubMed 29963011

  • Castillo JC, Fuentes A, Ortiz JA, Abellan E, Bernabeu A, Bernabeu R. Continuous ovarian stimulation: a proof-of-concept study exploring the uninterrupted use of corifollitropin alpha in DuoStim cycles for enhanced efficiency and patient convenience (Alicante protocol). F S Rep. 2024 Mar 28;5(2):176-182. doi: 10.1016/j.xfre.2024.03.005. eCollection 2024 Jun.

    PubMed 38983736

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Corifollitropin Alfa, Follitropin Alfa and Follitropin Alfa Biosimilar in people with Fertility Issues, run by Instituto Bernabeu at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Retrieved Oocytes (time frame: Through study completion, an average of four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05815719, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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