Back to resultsContinuous Double Ovarian Stimulation.
Primary Purpose
Fertility Issues
Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Corifollitropin Alfa
Follitropin Alfa
Follitropin Alfa Biosimilar
Urinary Human follicle stimulating hormone
Sponsored by
About this trial
This is an interventional treatment trial for Fertility Issues focused on measuring OVARIAN STIMULATION
Eligibility Criteria
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.
Sites / Locations
- Instituto BernabeuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control group
Arm Description
Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.
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).
Outcomes
Primary Outcome Measures
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
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).
Secondary Outcome Measures
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.
duration of DUOSTIM cycle - comparison
To assess whether there are differences between the two groups concerning the duration of stimulation.
fertilization rate - comparison
To assess whether there are differences between both groups regarding the fertilization rate.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05815719
Brief Title
Continuous Double Ovarian Stimulation.
Official Title
Continuous Ovarian Stimulation in DUOSTIM Cycles.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Bernabeu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility Issues
Keywords
OVARIAN STIMULATION
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Corifollitropin Alfa
Other Intervention Name(s)
4 Weekly Corifollitropin Alfa injections
Intervention Description
150 micrograms per dose
Intervention Type
Drug
Intervention Name(s)
Follitropin Alfa
Other Intervention Name(s)
Daily injections of gonadotropins
Intervention Description
Variable dose.
Intervention Type
Drug
Intervention Name(s)
Follitropin Alfa Biosimilar
Other Intervention Name(s)
Daily injections of gonadotropins
Intervention Description
Variable dose.
Intervention Type
Drug
Intervention Name(s)
Urinary Human follicle stimulating hormone
Other Intervention Name(s)
Daily injections of gonadotropins
Intervention Description
Variable dose.
Primary Outcome Measure Information:
Title
number of retrieved oocytes - study group
Description
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
Time Frame
Through study completion, an average of four months
Title
number of retrieved oocytes - comparison
Description
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).
Time Frame
Through study completion, an average of four months
Secondary Outcome Measure Information:
Title
number of MII oocytes - comparison
Description
To assess whether there exist any differences between the two groups with respect to the rate of metaphase II (MII) oocytes.
Time Frame
Through study completion, an average of four months
Title
duration of DUOSTIM cycle - comparison
Description
To assess whether there are differences between the two groups concerning the duration of stimulation.
Time Frame
Through study completion, an average of four months
Title
fertilization rate - comparison
Description
To assess whether there are differences between both groups regarding the fertilization rate.
Time Frame
Through study completion, an average of four months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Given the aim is to carry out ovarian stimulation, only persons with female reproductive system can be eligible.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Pitas, PhD
Phone
+34965154000
Email
apitas@institutobernabeu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Carlos Castillo Farfan, MD, PhD
Phone
+34965154000
Email
jcastillo@institutobernabeu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Castillo Farfan, MD, PhD
Organizational Affiliation
Instituto Bernabeu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Bernabeu
City
Alicante
ZIP/Postal Code
03016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Pitas, PhD
Phone
+34965154000
Email
apitas@institutobernabeu.com
First Name & Middle Initial & Last Name & Degree
Juan Carlos Castillo Farfan, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The PI will collect individual data which will later be analyzed. Only analyzed overall data will be shared.
Citations:
PubMed Identifier
12748128
Citation
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.
Results Reference
result
PubMed Identifier
19684043
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.
Results Reference
result
PubMed Identifier
25444501
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. Epub 2014 Sep 6.
Results Reference
result
PubMed Identifier
24161646
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 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.
Results Reference
result
PubMed Identifier
32338123
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 purposes. A systematic review. Ups J Med Sci. 2020 May;125(2):121-130. doi: 10.1080/03009734.2020.1734694. Epub 2020 Apr 25.
Results Reference
result
PubMed Identifier
29963011
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: A Multicenter Experience and SWOT Analysis. Front Endocrinol (Lausanne). 2018 Jun 14;9:317. doi: 10.3389/fendo.2018.00317. eCollection 2018.
Results Reference
result
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Continuous Double Ovarian Stimulation.
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