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2-Shot: Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.

Sponsor
Fundación Santiago Dexeus Font (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06134479
Collaborator
Organon (Industry)
194
Enrollment
1
Location
2
Arms
25.7
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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 undergoing elective fertility preservation in a progestin-primed ovarian stimulation (PPOS) protocol and GnRH-agonist (GnRH-a) triggering.

Condition or Disease Intervention/Treatment Phase
  • Drug: 150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5
  • Drug: 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.. The 2-shot Protocol.
Anticipated Study Start Date :
Nov 10, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 150μg CFA at SD 1 following by rFSH 200IU daily from SD 8

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

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

Outcome Measures

Primary Outcome Measures

  1. Number of MII oocytes retrieved [Trough study completion, an average of 10-20 days.]

    Number of MII oocytes retrieved

Secondary Outcome Measures

  1. Total number of oocytes retrieved [Trough study completion, an average of 10-20 days.]

    Total number of oocytes retrieved

  2. FSH [Up to oocyte pickup, an average of 10-20 days.]

    Endocrine profile FSH

  3. LH [Up to oocyte pickup, an average of 10-20 days.]

    Endocrine profile LH

  4. PROGESTERONE [Up to oocyte pickup, an average of 10-20 days.]

    Endocrine profile PROGESTERONE

  5. Estradiol [Up to oocyte pickup, an average of 10-20 days.]

    Endocrine profile Estradiol

  6. OHSS [Until 15 days after day of oocyte pick-up]

    Incidence of OHSS

  7. FertiQoL [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 [up to 18 days]

    Total days of stimulation

  9. Adverse events [up to 20days]

    Frequency of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Quiron Dexeus Barcelona Spain 08028

Sponsors and Collaborators

  • Fundación Santiago Dexeus Font
  • Organon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Fundación Santiago Dexeus Font
ClinicalTrials.gov Identifier:
NCT06134479
Other Study ID Numbers:
  • FSD-SEQ-2023-09
  • 2023-506162-31
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2023