Continuous Double Ovarian Stimulation.

Fertility Issues Clinical Trial

Official title:

Continuous Ovarian Stimulation in DUOSTIM Cycles.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815719
• Other study ID #: IBMR31
• Secondary ID: 2022-003177-32
• Status: Recruiting
• Phase: Phase 4
• Start date: November 17, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: April 2023
• Source: Instituto Bernabeu
• Contact: Anna Pitas, PhD
• Phone: +34965154000
• Email: apitas[@]institutobernabeu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this pilot study is to evaluate the efficacy of the weekly use of corifollitropin alfa in terms of ovarian stimulation results and its biological outcomes (total number of oocytes retrieved) in case of ovarian stimulation cycles in double stimulation modality (DUOSTIM) and in comparison with the conventional DUOSTIM protocol: daily administration of gonadotropins.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fertility Issues
• Infertility

Intervention

Drug:
• Corifollitropin Alfa
150 micrograms per dose
• Follitropin Alfa
Variable dose.
• Follitropin Alfa Biosimilar
Variable dose.
• Urinary Human follicle stimulating hormone
Variable dose.

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — 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 anta — View Citation

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. — View Citation

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 fr — View Citation

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 pu — View Citation

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of retrieved oocytes - study group	To investigate the total number of oocytes retrieved through ovarian stimulation in double ovarian stimulation (DUOSTIM) cycles utilizing weekly subcutaneous injections of Corifollitropin alfa during DUOSTIM stimulation	Through study completion, an average of four months
Primary	number of retrieved oocytes - comparison	To compare the total number of oocytes obtained in the study group with the outcomes of historical data collected from conventional DUOSTIM cycles that employed the conventional protocol (consisting of daily subcutaneous injections of gonadotropins).	Through study completion, an average of four months
Secondary	number of MII oocytes - comparison	To assess whether there exist any differences between the two groups with respect to the rate of metaphase II (MII) oocytes.	Through study completion, an average of four months
Secondary	duration of DUOSTIM cycle - comparison	To assess whether there are differences between the two groups concerning the duration of stimulation.	Through study completion, an average of four months
Secondary	fertilization rate - comparison	To assess whether there are differences between both groups regarding the fertilization rate.	Through study completion, an average of four months