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

NCT04122729 | Unknown

• 1 other identifier: ANG-FOS-2019-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 12

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.

Conditions

In Vitro Fertilization; Controlled Ovarian Stimulation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Oocytes retrieved

  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).

  Through study completion, an average of 1 year

• Genotype of the N680S polymorphism of the FSHR gene

  Genotype of the N680S polymorphism of the FSHR gene will be tested on blood samples

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Genotype of the N312S polymorphism of the LHCGR gene

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)
• recovered oocytes in the 1st cycle of COS
• ≤ 6 months between the 2 cycles of COS

You may not qualify if:

• 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

Sponsors & Collaborators

• Angelini Farmacéutica: lead
• Sistemas Genómicos: collaborator

Study Sites (12)

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

RECRUITING

Hospital Clínic

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Spain

NOT YET RECRUITING

Hospital Virgen de las Nieves

Granada, Spain

NOT YET RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

NOT YET RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Hospital Universitario Príncipe de Asturias

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, Spain

NOT YET RECRUITING

Hospital Clínico Universitario Valladolid

Valladolid, Spain

NOT YET RECRUITING

Related Publications (40)

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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.

Study Officials

• María Carrera, PhD

  Hospital Universitario 12 de Octubre

  STUDY DIRECTOR

Central Study Contacts

Cristina Macarrilla

CONTACT

+34 932 534 643; cristina.macarrilla@angelinipharma.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 10, 2019
• Study Start: September 25, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

ES (12)