N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS
NCT ID: NCT04122729
Last Updated: 2019-10-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
300 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-09-25
Study Completion Date
2020-06-30
Brief Summary
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This project wants to determinate whether there is a relationship between the N680S polymorphism genotype of the FSHR gene and the nature of the FSH used in controlled ovarian stimulation.
It is a non-interventional, observational, cross-sectional and retrospective, national and multicenter study, in which a genetic test will be carried out to determine the genotype of the N680S polymorphism in samples of blood of patients who have undergone two cycles of controlled ovarian stimulation in the last 8 months.
It is a non-interventional, observational, cross-sectional and retrospective, national and multicenter study, in which a genetic test will be carried out to determine the genotype of the N680S polymorphism in samples of blood of patients who have undergone two cycles of controlled ovarian stimulation in the last 8 months.
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Detailed Description
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The investigators want to investigate whether the N680S polymorphism of the FSRH gene could affects ovarian response with different nature of the FSH used (human FSH and recombinant FSH) in patients undergoing two consecutive cycles of IVF/ICSI with controlled ovarian stimulation.
All patients who agree to participate in the study will have a blood sample taken on the same day as a routine extraction performed for the 2nd cycle of the controlled ovarian stimulation in accordance with the standard clinical practice of each hospital. The sample will be sent to the central laboratory to determine the genotype of the afore mentioned polymorphism and correlate it with the clinical results obtained with the two cycles of controlled ovarian stimulation.
In order to avoid any bias, the study population will follow a crossover design with respect to the type of FSH used in the first and second cycles of the COS (i.e., half of the recruited patients must have undergone a first cycle of COS with recombinant FSH and a second cycle with human FSH; and, conversely, the other half must have undergone a first cycle with human FSH and a second cycle with recombinant FSH). In order to avoid potential modifications to the inclusion criteria, the time elapsed between the two cycles should not exceed 6 months.
All patients who agree to participate in the study will have a blood sample taken on the same day as a routine extraction performed for the 2nd cycle of the controlled ovarian stimulation in accordance with the standard clinical practice of each hospital. The sample will be sent to the central laboratory to determine the genotype of the afore mentioned polymorphism and correlate it with the clinical results obtained with the two cycles of controlled ovarian stimulation.
In order to avoid any bias, the study population will follow a crossover design with respect to the type of FSH used in the first and second cycles of the COS (i.e., half of the recruited patients must have undergone a first cycle of COS with recombinant FSH and a second cycle with human FSH; and, conversely, the other half must have undergone a first cycle with human FSH and a second cycle with recombinant FSH). In order to avoid potential modifications to the inclusion criteria, the time elapsed between the two cycles should not exceed 6 months.
Conditions
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In Vitro Fertilization
Controlled Ovarian Stimulation
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Signature of Informed Consent
* Age ≤ 37 years
* BMI \< 30 kg/m2
* Antral follicles count 1st cycle COS = 5-15
* Antimüllerian hormone basal 1st cycle COS \> 1,1 ng/ml and \< 3,1 ng/ml
* COS protocol: equal starting dose in the 2 cycles of COS (150-225 UI/day) with dose adjustment from the 5th day of COS; pituitary suppression protocol in the 2 cycles of COS with GnRH antagonist with onset when ≥ 1 follicle of ≥ 14 mm in diameter or E2 ≤ 600 pg/ml; and triggering with hCGr or GnRH agonist
* Optional the use of oral contraceptives (OC) (however, same in the 2 cycles)
* 4-9 recovered oocytes in the 1st cycle of COS
* ≤ 6 months between the 2 cycles of COS
* Age ≤ 37 years
* BMI \< 30 kg/m2
* Antral follicles count 1st cycle COS = 5-15
* Antimüllerian hormone basal 1st cycle COS \> 1,1 ng/ml and \< 3,1 ng/ml
* COS protocol: equal starting dose in the 2 cycles of COS (150-225 UI/day) with dose adjustment from the 5th day of COS; pituitary suppression protocol in the 2 cycles of COS with GnRH antagonist with onset when ≥ 1 follicle of ≥ 14 mm in diameter or E2 ≤ 600 pg/ml; and triggering with hCGr or GnRH agonist
* Optional the use of oral contraceptives (OC) (however, same in the 2 cycles)
* 4-9 recovered oocytes in the 1st cycle of COS
* ≤ 6 months between the 2 cycles of COS
Exclusion Criteria
* Use of the LH activity during the cycles of COS
* Presence of severe male factor
* Grade III-IV endometriosis
* Patients with polycystic ovary syndrome, a history of uterine or ovarian surgeries, hydrosalpinx visible by ultrasound, or uterine fibroids measuring \> 30 mm
* Major systemic or uncontrolled endocrine-metabolic diseases affecting the pituitary gland, the thyroid gland, the adrenal glands, the pancreas, the liver, or the kidneys
* Presence of severe male factor
* Grade III-IV endometriosis
* Patients with polycystic ovary syndrome, a history of uterine or ovarian surgeries, hydrosalpinx visible by ultrasound, or uterine fibroids measuring \> 30 mm
* Major systemic or uncontrolled endocrine-metabolic diseases affecting the pituitary gland, the thyroid gland, the adrenal glands, the pancreas, the liver, or the kidneys
Minimum Eligible Age
18 Years
Maximum Eligible Age
37 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Sistemas Genómicos
UNKNOWN
Sponsor Role
collaborator
Angelini Farmacéutica
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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María Carrera, PhD
Role: STUDY_DIRECTOR
Hospital Universitario 12 de Octubre
Locations
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Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Site Status
RECRUITING
Hospital Clínic
Barcelona, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Universitario Reina Sofía
Córdoba, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Virgen de las Nieves
Granada, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Clínico San Carlos
Madrid, , Spain
Site Status
NOT_YET_RECRUITING
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Site Status
RECRUITING
Hospital Universitario 12 de Octubre
Madrid, , Spain
Site Status
RECRUITING
Hospital Universitario La Paz
Madrid, , Spain
Site Status
RECRUITING
Hospital Universitario Príncipe de Asturias
Madrid, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Clínico Universitario Valladolid
Valladolid, , Spain
Site Status
NOT_YET_RECRUITING
Countries
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Spain
Central Contacts
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Facility Contacts
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Berta Mª Martín, PhD
Role: primary
Dolors Manau, PhD
Role: primary
Julio Herrero, PhD
Role: primary
Juan Lorente, PhD
Role: primary
Luis Martínez, PhD
Role: primary
Mª Isabel Calventus, PhD
Role: primary
Miguel Caballero, PhD
Role: primary
Laura de la Fuente, PhD
Role: primary
+34 917 452 520
Sonia Lobo, PhD
Role: primary
+34 917 277 219
Irene Heras, PhD
Role: primary
José Mª Rubio, PhD
Role: primary
Ana Casas, PhD
Role: primary
References
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Other Identifiers
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ANG-FOS-2019-01
Identifier Type: -
Identifier Source: org_study_id
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