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

Fertility Clinical Trial

— 2-Shot  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134479
• Other study ID #: FSD-SEQ-2023-09
• Secondary ID: 2023-506162-31
• Status: Recruiting
• Phase: Phase 3
• Start date: December 12, 2023
• Est. completion date: January 2026

Study information

• Verified date: December 2023
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: January 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fertility

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Quiron Dexeus	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Santiago Dexeus Font	Organon

Country where clinical trial is conducted

Spain, 

References & Publications (28)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Fertil Steril. 2020 Dec;114(6):1358. — View Citation

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. — View Citation

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. Erratum In: Hum Reprod. 2014 May;29(5):1116-20. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

La Marca A, D'Ippolito G. Ovarian response markers lead to appropriate and effective use of corifollitropin alpha in assisted reproduction. Reprod Biomed Online. 2014 Feb;28(2):183-90. doi: 10.1016/j.rbmo.2013.10.012. Epub 2013 Oct 25. — View Citation

Ledger WL, Fauser BC, Devroey P, Zandvliet AS, Mannaerts BM. Corifollitropin alfa doses based on body weight: clinical overview of drug exposure and ovarian response. Reprod Biomed Online. 2011 Aug;23(2):150-9. doi: 10.1016/j.rbmo.2011.04.002. Epub 2011 Apr 15. — View Citation

Lerman T, Depenbusch M, Schultze-Mosgau A, von Otte S, Scheinhardt M, Koenig I, Kamischke A, Macek M, Schwennicke A, Segerer S, Griesinger G. Ovarian response to 150 microg corifollitropin alfa in a GnRH-antagonist multiple-dose protocol: a prospective cohort study. Reprod Biomed Online. 2017 May;34(5):534-540. doi: 10.1016/j.rbmo.2017.02.012. Epub 2017 Mar 2. — View Citation

Loutradis D, Vlismas A, Drakakis P. Corifollitropin alfa: a novel long-acting recombinant follicle-stimulating hormone agonist for controlled ovarian stimulation. Womens Health (Lond). 2010 Sep;6(5):655-64. doi: 10.2217/whe.10.56. — View Citation

Mahmoud Youssef MA, van Wely M, Aboulfoutouh I, El-Khyat W, van der Veen F, Al-Inany H. Is there a place for corifollitropin alfa in IVF/ICSI cycles? A systematic review and meta-analysis. Fertil Steril. 2012 Apr;97(4):876-85. doi: 10.1016/j.fertnstert.2012.01.092. Epub 2012 Jan 23. Erratum In: Fertil Steril. 2012 Jun;97(6):1479. — View Citation

Martinez F, Clua E, Garcia S, Coroleu B, Polyzos NP, Barri PN. Does LH suppression by progesterone-primed ovarian stimulation compared with GnRH antagonist affect live birth rate among oocyte recipients? Reprod Biomed Online. 2020 May;40(5):661-667. doi: 10.1016/j.rbmo.2020.01.016. Epub 2020 Jan 25. — View Citation

Martinez F, Rodriguez-Purata J, Beatriz Rodriguez D, Clua E, Rodriguez I, Coroleu B. Desogestrel versus antagonist injections for LH suppression in oocyte donation cycles: a crossover study. Gynecol Endocrinol. 2019 Oct;35(10):878-883. doi: 10.1080/09513590.2019.1604661. Epub 2019 May 7. — View Citation

Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047. — View Citation

Polyzos NP, Corona R, Van De Vijver A, Blockeel C, Drakopoulos P, Vloeberghs V, De Vos M, Camus M, Humaidan P, Tournaye H. Corifollitropin alfa followed by hpHMG in GnRH agonist protocols. Two prospective feasibility studies in poor ovarian responders. Gynecol Endocrinol. 2015;31(11):885-90. doi: 10.3109/09513590.2015.1065481. Epub 2015 Jul 14. — View Citation

Polyzos NP, Devos M, Humaidan P, Stoop D, Ortega-Hrepich C, Devroey P, Tournaye H. Corifollitropin alfa followed by rFSH in a GnRH antagonist protocol for poor ovarian responder patients: an observational pilot study. Fertil Steril. 2013 Feb;99(2):422-6. doi: 10.1016/j.fertnstert.2012.09.043. Epub 2012 Oct 16. — View Citation

Polyzos NP, Tournaye H, Guzman L, Camus M, Nelson SM. Predictors of ovarian response in women treated with corifollitropin alfa for in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2013 Aug;100(2):430-7. doi: 10.1016/j.fertnstert.2013.04.029. Epub 2013 May 10. — View Citation

Rombauts L, Talmor A. Corifollitropin alfa for female infertility. Expert Opin Biol Ther. 2012 Jan;12(1):107-12. doi: 10.1517/14712598.2012.641530. Epub 2011 Nov 30. — View Citation

Seyhan A, Ata B. The role of corifollitropin alfa in controlled ovarian stimulation for IVF in combination with GnRH antagonist. Int J Womens Health. 2011;3:243-55. doi: 10.2147/IJWH.S15002. Epub 2011 Aug 8. — View Citation

Tsakiridis I, Najdecki R, Tatsi P, Timotheou E, Kalinderi K, Michos G, Virgiliou A, Yarali H, Athanasiadis A, Papanikolaou EG. Evaluation of the safety and efficacy of corifollitropin alfa combined with GnRH agonist triggering in oocyte donation cycles. A prospective longitudinal study. JBRA Assist Reprod. 2020 Oct 6;24(4):436-441. doi: 10.5935/1518-0557.20200033. — View Citation

Vuong NL, Pham DT, Phung HT, Giang HN, Huynh GB, Nguyen TTL, Ho MT. Corifollitropin alfa vs recombinant FSH for controlled ovarian stimulation in women aged 35-42 years with a body weight >/=50 kg: a randomized controlled trial. Hum Reprod Open. 2017 Nov 28;2017(3):hox023. doi: 10.1093/hropen/hox023. eCollection 2017. — View Citation

Yovich JL, Keane KN, Borude G, Dhaliwal SS, Hinchliffe PM. Finding a place for corifollitropin within the PIVET FSH dosing algorithms. Reprod Biomed Online. 2018 Jan;36(1):47-58. doi: 10.1016/j.rbmo.2017.09.017. Epub 2017 Oct 31. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of MII oocytes retrieved	Number of MII oocytes retrieved	Trough study completion, an average of 10-20 days.
Secondary	Total number of oocytes retrieved	Total number of oocytes retrieved	Trough study completion, an average of 10-20 days.
Secondary	FSH	Endocrine profile FSH	Up to oocyte pickup, an average of 10-20 days.
Secondary	LH	Endocrine profile LH	Up to oocyte pickup, an average of 10-20 days.
Secondary	PROGESTERONE	Endocrine profile PROGESTERONE	Up to oocyte pickup, an average of 10-20 days.
Secondary	Estradiol	Endocrine profile Estradiol	Up to oocyte pickup, an average of 10-20 days.
Secondary	OHSS	Incidence of OHSS	Until 15 days after day of oocyte pick-up
Secondary	FertiQoL	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.
Secondary	Length of stimulation	Total days of stimulation	up to 18 days
Secondary	Adverse events	Frequency of adverse events	up to 20days

External Links

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