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N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS

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ClinicalTrials.gov Identifier: NCT04122729
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Sistemas Genómicos
Information provided by (Responsible Party):
Angelini Farmacéutica

Brief Summary:

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.


Condition or disease
In Vitro Fertilization Controlled Ovarian Stimulation

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Study of the N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in Controlled Ovarian Stimulation
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Oocytes retrieved [ Time Frame: Through study completion, an average of 1 year ]
    Number of oocytes retrieved in each IVF/ICSI cycle with controlled ovarian stimulation used different nature of the FSH in each one (human FSH and recombinant FSH).

  2. Genotype of the N680S polymorphism of the FSHR gene [ Time Frame: Through study completion, an average of 1 year ]
    Genotype of the N680S polymorphism of the FSHR gene will be tested on blood samples


Secondary Outcome Measures :
  1. Genotype of the N312S polymorphism of the LHCGR gene [ Time Frame: Through study completion, an average of 1 year ]
    Genotype of the N312S polymorphism of the LHCGR gene will be tested on blood samples


Biospecimen Retention:   Samples With DNA
Peripheral blood samples suitable for molecular analysis and DNA samples extraction. Once the determinations are made, these blood samples will be destroyed.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing two cycles of IVF/ICSI who achieved a suboptimal response after the 1st cycle, did not become pregnant, and consequently underwent another cycle of COS in which the protocol was amended during the 2nd cycle to change the nature of the FSH used during the 1st cycle.
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122729


Contacts
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Contact: Cristina Macarrilla +34 932 534 643 cristina.macarrilla@angelinipharma.com

Locations
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Spain
Hospital Universitario Fundación Alcorcón Recruiting
Alcorcón, Madrid, Spain
Contact: Berta Mª Martín, PhD         
Hospital Clínic Not yet recruiting
Barcelona, Spain
Contact: Dolors Manau, PhD         
Hospital Universitario Vall d'Hebron Not yet recruiting
Barcelona, Spain
Contact: Julio Herrero, PhD         
Hospital Universitario Reina Sofía Not yet recruiting
Córdoba, Spain
Contact: Juan Lorente, PhD         
Hospital Virgen de las Nieves Not yet recruiting
Granada, Spain
Contact: Luis Martínez, PhD         
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain
Contact: Mª Isabel Calventus, PhD         
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain
Contact: Miguel Caballero, PhD         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Contact: Laura de la Fuente, PhD    +34 917 452 520      
Hospital Universitario La Paz Recruiting
Madrid, Spain
Contact: Sonia Lobo, PhD    +34 917 277 219      
Hospital Universitario Príncipe de Asturias Not yet recruiting
Madrid, Spain
Contact: Irene Heras, PhD         
Hospital Universitario y Politécnico La Fe Not yet recruiting
Valencia, Spain
Contact: José Mª Rubio, PhD         
Hospital Clínico Universitario Valladolid Not yet recruiting
Valladolid, Spain
Contact: Ana Casas, PhD         
Sponsors and Collaborators
Angelini Farmacéutica
Sistemas Genómicos
Investigators
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Study Director: María Carrera, PhD Hospital Universitario 12 de Octubre

Publications:

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Responsible Party: Angelini Farmacéutica
ClinicalTrials.gov Identifier: NCT04122729     History of Changes
Other Study ID Numbers: ANG-FOS-2019-01
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Angelini Farmacéutica:
Highly purified human follicle stimulating hormone (HP-FSH)
Recombinant follicle stimulating hormone (rFSH)
FSH receptor (FSHR)
Polymorphism N680S of the FSHR
Polymorphism N312S of the LHCGR
LHCG receptor (LHCGR)
Polymorphism c.2039G>A
Polymorphism c.935A>G
Additional relevant MeSH terms:
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Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs