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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05815719
Other study ID # IBMR31
Secondary ID 2022-003177-32
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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