Continuous Double Ovarian Stimulation.

NCT05815719 | Completed Phase 4 Results

• 2 other identifiers: IBMR312022-003177-32
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of the weekly use of corifollitropin alfa in double ovarian stimulation process and to compare it to the conventional protocol with daily medication administration.

Conditions

Fertility Issues

Keywords

OVARIAN STIMULATION

Outcome Measures

Primary Outcomes (2)

• Total Number of Retrieved Oocytes

  To investigate the total number of oocytes retrieved through ovarian stimulation in double ovarian stimulation cycles (DUOSTIM) utilizing weekly subcutaneous injections of Corifollitropin alfa (study group) vs. daily injections of gonadotropins (control group).

  Through study completion, an average of four weeks

• Number of MII Oocytes

  To compare the total number of MII oocytes obtained in double stimulation cycles in study vs control groups

  Through study completion, an average of four months

Secondary Outcomes (2)

• Duration of Ovarian Stimulation

  Through study completion, an average of four months

• Number of Injections

  Through study completion, an average of four months

Study Arms (2)

Study group

EXPERIMENTAL

Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.

Drug: Corifollitropin Alfa

Control group

ACTIVE COMPARATOR

Patients to carry out a conventional double ovarian stimulation and to receive daily injections of gonadotropins. Retrospective group (data retrieved from strictly selected treatments carried out in our institution within the 24 months prior to the inclusion of the first patient in the study group and according to the standard guideline of the clinic).

Drug: Follitropin Alfa; Drug: Follitropin Alfa Biosimilar; Drug: Urinary Human follicle stimulating hormone

Interventions

Corifollitropin Alfa DRUG

150 micrograms per dose

Also known as: 4 Weekly Corifollitropin Alfa injections

Study group

Follitropin Alfa DRUG

Variable dose.

Also known as: Daily injections of gonadotropins

Control group

Follitropin Alfa Biosimilar DRUG

Variable dose.

Also known as: Daily injections of gonadotropins

Control group

Urinary Human follicle stimulating hormone DRUG

Variable dose.

Also known as: Daily injections of gonadotropins

Control group

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: Given the aim is to carry out ovarian stimulation, only persons with female reproductive system can be eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with indication for DUOSTIM protocol
• Maximum age of 43 years (up to one day before their 44th birthday) at the beginning of the stimulation process.
• Ability to participate and comply with the study protocol.
• To have given written consent

You may not qualify if:

• Finding of ovarian pathology at the time of initiation of stimulation: e.g. ovarian cysts.
• Concurrent participation in another study.

Sponsors & Collaborators

• Instituto Bernabeu: lead

Study Sites (1)

Instituto Bernabeu

Alicante, 03016, Spain

Location

Related Publications (7)

• Baerwald AR, Adams GP, Pierson RA. Characterization of ovarian follicular wave dynamics in women. Biol Reprod. 2003 Sep;69(3):1023-31. doi: 10.1095/biolreprod.103.017772. Epub 2003 May 14.

  PMID: 12748128 RESULT

• 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: 19684043 RESULT

• Kuang Y, Chen Q, Hong Q, Lyu Q, Ai A, Fu Y, Shoham Z. Double stimulations during the follicular and luteal phases of poor responders in IVF/ICSI programmes (Shanghai protocol). Reprod Biomed Online. 2014 Dec;29(6):684-91. doi: 10.1016/j.rbmo.2014.08.009. Epub 2014 Sep 6.

  PMID: 25444501 RESULT

• Kuang Y, Hong Q, Chen Q, Lyu Q, Ai A, Fu Y, Shoham Z. Luteal-phase ovarian stimulation is feasible for producing competent oocytes in women undergoing in vitro fertilization/intracytoplasmic sperm injection treatment, with optimal pregnancy outcomes in frozen-thawed embryo transfer cycles. Fertil Steril. 2014 Jan;101(1):105-11. doi: 10.1016/j.fertnstert.2013.09.007. Epub 2013 Oct 23.

  PMID: 24161646 RESULT

• Vaiarelli A, Cimadomo D, Petriglia C, Conforti A, Alviggi C, Ubaldi N, Ledda S, Ferrero S, Rienzi L, Ubaldi FM. DuoStim - a reproducible strategy to obtain more oocytes and competent embryos in a short time-frame aimed at fertility preservation and IVF purposes. A systematic review. Ups J Med Sci. 2020 May;125(2):121-130. doi: 10.1080/03009734.2020.1734694. Epub 2020 Apr 25.

  PMID: 32338123 RESULT

• Vaiarelli A, Cimadomo D, Trabucco E, Vallefuoco R, Buffo L, Dusi L, Fiorini F, Barnocchi N, Bulletti FM, Rienzi L, Ubaldi FM. Double Stimulation in the Same Ovarian Cycle (DuoStim) to Maximize the Number of Oocytes Retrieved From Poor Prognosis Patients: A Multicenter Experience and SWOT Analysis. Front Endocrinol (Lausanne). 2018 Jun 14;9:317. doi: 10.3389/fendo.2018.00317. eCollection 2018.

  PMID: 29963011 RESULT

• Castillo JC, Fuentes A, Ortiz JA, Abellan E, Bernabeu A, Bernabeu R. Continuous ovarian stimulation: a proof-of-concept study exploring the uninterrupted use of corifollitropin alpha in DuoStim cycles for enhanced efficiency and patient convenience (Alicante protocol). F S Rep. 2024 Mar 28;5(2):176-182. doi: 10.1016/j.xfre.2024.03.005. eCollection 2024 Jun.

  PMID: 38983736 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; follitropin alfa; Urofollitropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Menotropins; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The limitations of the present study correspond to the comparative with historical records and not blinding the patients. in addition, the study does not evaluate data on oocyte quality beyond fertilization.

Results Point of Contact

• Title: Juan Carlos Castillo
• Organization: Instituto Bernabeu

jcastillo@institutobernabeu.com

+34965154000

Study Officials

• Juan Carlos Castillo Farfan, MD, PhD

  Instituto Bernabeu

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 18, 2023
• Study Start: November 17, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: May 18, 2025
• Results First Posted: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)