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Trial · Interventional

CompletedPhase 3Registry data

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

Short name 2-Shot

NCTNCT06134479 (opens ClinicalTrials.gov in a new tab)Other idFSD-SEQ-2023-09Other id2023-506162-31Other id2023
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Triptorelin (Trelstar, Decapeptyl), does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 3
Enrollment
194 participants (actual)
Sponsor
Fundación Santiago Dexeus Font · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Spain

Start
18 Dec 2023
Primary completion
9 Sept 2025
Completion
9 Sept 2025
First posted
18 Nov 2023
Last update posted
23 Jun 2026
Conditions
Fertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 3

    2-Shot

    NCT06134479

    18 Dec 2023 to 9 Sept 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • 150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5Drug
  • 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the triggerDrug

Arms2

  • Active comparator

    150μg CFA at SD 1 following by rFSH 200IU daily from SD 8

  • Experimental

    150μg CFA at stimulation day (SD) 1 and 100μg CFA at SD 5

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of MII oocytes retrieved

    Time frame · Trough study completion, an average of 10-20 days.

    Registry description

    Number of MII oocytes retrieved

Secondary outcomes(9)

  1. Total number of oocytes retrieved

    Time frame · Trough study completion, an average of 10-20 days.

    Registry description

    Total number of oocytes retrieved

  2. FSH

    Time frame · Up to oocyte pickup, an average of 10-20 days.

    Registry description

    Endocrine profile FSH

  3. LH

    Time frame · Up to oocyte pickup, an average of 10-20 days.

    Registry description

    Endocrine profile LH

  4. PROGESTERONE

    Time frame · Up to oocyte pickup, an average of 10-20 days.

    Registry description

    Endocrine profile PROGESTERONE

  5. Estradiol

    Time frame · Up to oocyte pickup, an average of 10-20 days.

    Registry description

    Endocrine profile Estradiol

  6. OHSS

    Time frame · Until 15 days after day of oocyte pick-up

    Registry description

    Incidence of OHSS

  7. FertiQoL

    Time frame · from stimulation day 1 until the day of oocyte pick-up,10-20 days after the beggining of the stimulation.

    Registry description

    Quality of life questionnaire "FertiQoL"

  8. Length of stimulation

    Time frame · up to 18 days

    Registry description

    Total days of stimulation

  9. Adverse events

    Time frame · up to 20days

    Registry description

    Frequency of adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

7 results

Corifollitropin alfa for poor responders patients, a prospective randomized study.

Fusi et al. 2020Reproductive biology and endocrinology : RB&Ecited by 10

PMID 32646462PMC7346462DOI 10.1186/s12958-020-00628-6PUB-32646462

CC BY7 results
Download PDFSee results (7)

More studies

1 study on this page

Indexing hint: Observational study · 2020

Does LH suppression by progesterone-primed ovarian stimulation compared with GnRH antagonist affect live birth rate among oocyte recipients?

Martínez et al. 2020Reproductive biomedicine onlinecited by 10

PMID 32268981DOI 10.1016/j.rbmo.2020.01.016PUB-32268981

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedDonno V, Sachs-Guedj N, Devesa M, Garcia-Martinez S, Rodriguez I, Polyzos NP. The two-shot protocol. A randomized controlled trial of a novel two-injection ovarian stimulation strategy. Hum Reprod. 2026 Sep 25:deag142. doi: 10.1093/humrep/deag142. Online ahead of print. PMID 42786378

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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).

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