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

February 23, 2026 updated by: Fundación Santiago Dexeus Font

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Hospital Universitario Quiron Dexeus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of MII oocytes retrieved
Time Frame: Trough study completion, an average of 10-20 days.
Number of MII oocytes retrieved
Trough study completion, an average of 10-20 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of oocytes retrieved
Time Frame: Trough study completion, an average of 10-20 days.
Total number of oocytes retrieved
Trough study completion, an average of 10-20 days.
FSH
Time Frame: Up to oocyte pickup, an average of 10-20 days.
Endocrine profile FSH
Up to oocyte pickup, an average of 10-20 days.
LH
Time Frame: Up to oocyte pickup, an average of 10-20 days.
Endocrine profile LH
Up to oocyte pickup, an average of 10-20 days.
PROGESTERONE
Time Frame: Up to oocyte pickup, an average of 10-20 days.
Endocrine profile PROGESTERONE
Up to oocyte pickup, an average of 10-20 days.
Estradiol
Time Frame: Up to oocyte pickup, an average of 10-20 days.
Endocrine profile Estradiol
Up to oocyte pickup, an average of 10-20 days.
OHSS
Time Frame: Until 15 days after day of oocyte pick-up
Incidence of OHSS
Until 15 days after day of oocyte pick-up
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"
from stimulation day 1 until the day of oocyte pick-up,10-20 days after the beggining of the stimulation.
Length of stimulation
Time Frame: up to 18 days
Total days of stimulation
up to 18 days
Adverse events
Time Frame: up to 20days
Frequency of adverse events
up to 20days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Santiago Dexeus Font

Collaborators

Organon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Actual)

September 9, 2025

Study Completion (Actual)

September 9, 2025

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSD-SEQ-2023-09
  • 2023-506162-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fertility

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe