AzTrials
AzTrials

FertilityPhase 32-ShotNCT06134479

Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.

A Phase 3 study testing 150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5 and 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger in people with Fertility, run by Fundación Santiago Dexeus Font 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

This randomized was designed as non-inferiority trial aiming to compare the number of MII oocytes with 2-shot of Corifollitropin alpha (CFA) sequential administration: 150μg at stimulation day (SD) 1 and 100μg at SD 5 and 1-shot of CFA administration 150μg at SD 1 following by rFSH 200IU daily from SD 8 in women… Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Fertility
What is being tested?
150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5 and 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
1 siteSpain
Study dates
18 Dec 2023to 9 Sep 2025
Phase
Phase 3
Are there results?
None posted in the registry

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 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • AFC ≤20
  • Anti-Mullerian hormone (AMH) ≤3ng/ml (AMH result of up to one year will be valid)
  • Between 18 and 40 years old
  • BMI >18 and <30 kg/m2
  • Body weight > 50 kg for > 36 years
  • Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation.

Who cannot join

  • Medically indicated fertility preservation
  • AFC > 20
  • Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria
  • FSH ≥ 20
  • History of untreated autoimmune, endocrine or metabolic disorders
  • Contraindication for hormonal treatment
  • Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Quiron Dexeus

    Barcelona, 08028

Other trials in Spain

About this study

Official title: Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.. The 2-shot Protocol.

This randomized was designed as non-inferiority trial aiming to compare the number of MII oocytes with 2-shot of Corifollitropin alpha (CFA) sequential administration: 150μg at stimulation day (SD) 1 and 100μg at SD 5 and 1-shot of CFA administration 150μg at SD 1 following by rFSH 200IU daily from SD 8 in women undergoing elective fertility preservation in a progestin-primed ovarian stimulation (PPOS) protocol and GnRH-agonist (GnRH-a) triggering.

Conditions
Fertility
Being tested
150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5, 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger

What participants receive

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

  • 150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5Drug

    On Day 2 or 3 of the menstrual cycle, a first subcutaneous (SC) injection of corifollitropin alfa (CFA) (Elonva®) 150μg will be administered (stimulation day 1) and a second SC injection of corifollitropin alfa (Elonva®) 100 μg will be administrated on SD 5. Endogenous LH suppression will be accomplished by daily 75μg/day of Desogestrel (Cerazet®) per os, at bedtime, starting on stimulation day 1 and continuing up to the day before of trigger. As soon as 3 follicles ≥ 18 mm are observed by ultrasound, 0.2 mg Triptorelin (Decapeptyl®) will be administered the same day to induce final oocyte maturation. About 34-36 hours thereafter oocyte pick-up will be performed.

  • 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the triggerDrug

    On Day 2 or 3 of the menstrual cycle, a single subcutaneous (SC) injection of corifollitropin alfa (Elonva®) 150μg will be administered (SD 1) and from Day 8 of stimulation a daily SC dose of rFSH (Puregon®) 200IU/day up to the day of Triptorelin (Decapeptyl®) 0.2 mg administration. Endogenous LH suppression will be accomplished by daily 75μg/day of Desogestrel (Cerazet®) per os, at bedtime, starting on stimulation day 1 and continuing up to the day before of trigger. As soon as 3 follicles ≥ 18 mm are observed by ultrasound, 0.2 mg Triptorelin (Decapeptyl®) will be administered the same day to induce final oocyte maturation. About 34-36 hours thereafter oocyte pick-up will be performed.

Study groups in NCT06134479
Study groupRoleWhat they receive
150μg CFA at SD 1 following by rFSH 200IU daily from SD 8Active comparatorNot described
Receives: Drug: 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger
150μg CFA at stimulation day (SD) 1 and 100μg CFA at SD 5ExperimentalNot described
Receives: Drug: 150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5

What is being measured

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

  1. Number of MII oocytes retrieved

    Number of MII oocytes retrieved

    Measured: Trough study completion, an average of 10-20 days.

Secondary outcomes (9)

  1. Total number of oocytes retrieved

    Total number of oocytes retrieved

    Measured: Trough study completion, an average of 10-20 days.

  2. FSH

    Endocrine profile FSH

    Measured: Up to oocyte pickup, an average of 10-20 days.

  3. LH

    Endocrine profile LH

    Measured: Up to oocyte pickup, an average of 10-20 days.

  4. PROGESTERONE

    Endocrine profile PROGESTERONE

    Measured: Up to oocyte pickup, an average of 10-20 days.

  5. Estradiol

    Endocrine profile Estradiol

    Measured: Up to oocyte pickup, an average of 10-20 days.

  6. OHSS

    Incidence of OHSS

    Measured: Until 15 days after day of oocyte pick-up

  7. FertiQoL

    Quality of life questionnaire "FertiQoL"

    Measured: from stimulation day 1 until the day of oocyte pick-up,10-20 days after the beggining of the stimulation.

  8. Length of stimulation

    Total days of stimulation

    Measured: up to 18 days

  9. Adverse events

    Frequency of adverse events

    Measured: up to 20days

Timeline

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

  1. First posted18 Nov 2023
  2. Study start18 Dec 2023
  3. Primary completion9 Sep 2025
  4. Study completion9 Sep 2025

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06134479
Sponsor's protocol ID
FSD-SEQ-2023-09
Other IDs
2023-506162-31, 2023
Acronym
2-Shot
Status last verified
Jun 2026
First submitted
2 Nov 2023
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.

    PubMed 30927417

  • Benchabane M, Santulli P, Maignien C, Bourdon M, De Ziegler D, Chapron C, Gayet V. [Corifollitropin alfa compared to daily FSH in controlled ovarian stimulation for oocyte donors]. Gynecol Obstet Fertil Senol. 2017 Feb;45(2):83-88. doi: 10.1016/j.gofs.2016.12.022. Epub 2017 Feb 16. French.

    PubMed 28368800

  • Blockeel C, Polyzos NP, Derksen L, De Brucker M, Vloeberghs V, van de Vijver A, De Vos M, Tournaye H. Administration of corifollitropin alfa on Day 2 versus Day 4 of the cycle in a GnRH antagonist protocol: a randomized controlled pilot study. Hum Reprod. 2014 Jul;29(7):1500-7. doi: 10.1093/humrep/deu105. Epub 2014 May 9.

    PubMed 24813196

  • Cozzolino M, Vitagliano A, Cecchino GN, Ambrosini G, Garcia-Velasco JA. Corifollitropin alfa for ovarian stimulation in in vitro fertilization: a systematic review and meta-analysis of randomized controlled trials. Fertil Steril. 2019 Apr;111(4):722-733. doi: 10.1016/j.fertnstert.2018.11.047.

    PubMed 30929731

  • Croxtall JD, McKeage K. Corifollitropin alfa: a review of its use in controlled ovarian stimulation for assisted reproduction. BioDrugs. 2011 Aug 1;25(4):243-54. doi: 10.2165/11206890-000000000-00000.

    PubMed 21815699

  • 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

  • Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.

    PubMed 21828116

  • Drakopoulos P, Vuong TNL, Ho NAV, Vaiarelli A, Ho MT, Blockeel C, Camus M, Lam AT, van de Vijver A, Humaidan P, Tournaye H, Polyzos NP. Corifollitropin alfa followed by highly purified HMG versus recombinant FSH in young poor ovarian responders: a multicentre randomized controlled clinical trial. Hum Reprod. 2017 Nov 1;32(11):2225-2233. doi: 10.1093/humrep/dex296.

    PubMed 29040589

  • Fusi FM, Zanga L, Arnoldi M, Melis S, Cappato M, Candeloro I, Di Pasqua A. Corifollitropin alfa for poor responders patients, a prospective randomized study. Reprod Biol Endocrinol. 2020 Jul 9;18(1):67. doi: 10.1186/s12958-020-00628-6.

    PubMed 32646462

  • Giles J, Alama P, Gamiz P, Vidal C, Badia P, Pellicer A, Bosch E. Medroxyprogesterone acetate is a useful alternative to a gonadotropin-releasing hormone antagonist in oocyte donation: a randomized, controlled trial. Fertil Steril. 2021 Aug;116(2):404-412. doi: 10.1016/j.fertnstert.2021.02.036. Epub 2021 Apr 2.

    PubMed 33814126

  • Hwang JL, Chen SU, Chen HJ, Chen HF, Yang YS, Chang CH, Seow KM, Tzeng CR, Lin YH. Feasibility of corifollitropin alfa/GnRH antagonist protocol combined with GnRH agonist triggering and freeze-all strategy in polycystic ovary syndrome patients. J Formos Med Assoc. 2018 Jun;117(6):535-540. doi: 10.1016/j.jfma.2017.05.009. Epub 2017 Aug 19.

    PubMed 28830648

  • La Marca A, Capuzzo M. Use of progestins to inhibit spontaneous ovulation during ovarian stimulation: the beginning of a new era? Reprod Biomed Online. 2019 Aug;39(2):321-331. doi: 10.1016/j.rbmo.2019.03.212. Epub 2019 Mar 29.

    PubMed 31138494

  • La Marca A, D'Ippolito G. Ovarian response markers lead to appropriate and effective use of corifollitropin alpha in assisted reproduction. Reprod Biomed Online. 2014 Feb;28(2):183-90. doi: 10.1016/j.rbmo.2013.10.012. Epub 2013 Oct 25.

    PubMed 24368127

  • Ledger WL, Fauser BC, Devroey P, Zandvliet AS, Mannaerts BM. Corifollitropin alfa doses based on body weight: clinical overview of drug exposure and ovarian response. Reprod Biomed Online. 2011 Aug;23(2):150-9. doi: 10.1016/j.rbmo.2011.04.002. Epub 2011 Apr 15.

    PubMed 21665541

  • Lerman T, Depenbusch M, Schultze-Mosgau A, von Otte S, Scheinhardt M, Koenig I, Kamischke A, Macek M, Schwennicke A, Segerer S, Griesinger G. Ovarian response to 150 microg corifollitropin alfa in a GnRH-antagonist multiple-dose protocol: a prospective cohort study. Reprod Biomed Online. 2017 May;34(5):534-540. doi: 10.1016/j.rbmo.2017.02.012. Epub 2017 Mar 2.

    PubMed 28285952

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5 and 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger in people with Fertility, run by Fundación Santiago Dexeus Font 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 6 inclusion and 7 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 23 Jun 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of MII oocytes retrieved (time frame: Trough study completion, an average of 10-20 days.). 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 NCT06134479, which also lists 29 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 23 Jun 2026.

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