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NCT06134479·Phase 3·INTERVENTIONAL

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

TriptorelinOtherCompleted

Status

Completed

Phase

Phase 3

Enrollment

194

Locations

1

Results

Not posted

Publications

12

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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.

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.

Timeline

From registration to results.

  1. First posted

    Nov 18, 2023

  2. Study start

    Dec 18, 2023

  3. Primary completion

    Sep 9, 2025

  4. Study completion

    Sep 9, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Jun 23, 2026

Outcomes

What the study measures.

Primary outcomes

Number of MII oocytes retrieved

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

Number of MII oocytes retrieved

Secondary outcomes

Total number of oocytes retrieved

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

Total number of oocytes retrieved

FSH

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

Endocrine profile FSH

LH

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

Endocrine profile LH

PROGESTERONE

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

Endocrine profile PROGESTERONE

Estradiol

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

Endocrine profile Estradiol

OHSS

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

Incidence of OHSS

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"

Length of stimulation

Time frame · up to 18 days

Total days of stimulation

Adverse events

Time frame · up to 20days

Frequency of adverse events

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
40 Years
Sex
FEMALE
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).

Study locations

1 registered sites.

Spain. Showing up to 24 locations stored in the fast local snapshot.

Hospital Universitario Quiron Dexeus

Barcelona, Spain

Publications

Results and literature.

PMID 30927417 ↗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.PMID 28368800 ↗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.PMID 24813196 ↗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.PMID 30929731 ↗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.PMID 21815699 ↗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.PMID 19684043 ↗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.PMID 21828116 ↗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.PMID 29040589 ↗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.PMID 32646462 ↗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.PMID 33814126 ↗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.PMID 28830648 ↗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.PMID 31138494 ↗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.

Primary links

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