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Completed

NCT Number: NCT06134479

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

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.

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Key information

Conditions

Fertility

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Quiron Dexeus

Barcelona, 08028, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Drug

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 trigger

Drug

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.

Primary outcomes

  1. Number of MII oocytes retrieved

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

    Number of MII oocytes retrieved

Secondary outcomes

  1. Total number of oocytes retrieved

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

    Total number of oocytes retrieved

  2. FSH

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

    Endocrine profile FSH

  3. LH

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

    Endocrine profile LH

  4. PROGESTERONE

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

    Endocrine profile PROGESTERONE

  5. Estradiol

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

    Endocrine profile Estradiol

  6. OHSS

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

    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.

    Quality of life questionnaire "FertiQoL"

  8. Length of stimulation

    Time frame: up to 18 days

    Total days of stimulation

  9. Adverse events

    Time frame: up to 20days

    Frequency of adverse events

Sponsors and collaborators

Lead sponsor

Fundación Santiago Dexeus Font

Other

Collaborators

  • Organon

Registry information

Official study title

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

Acronym: 2-Shot

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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