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

In Vitro Fertilization Clinical Trial

Official title:

Study of the N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in Controlled Ovarian Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122729
• Other study ID #: ANG-FOS-2019-01
• Status: Recruiting
• Start date: September 25, 2019
• Est. completion date: June 2020

Study information

• Verified date: October 2019
• Source: Angelini Farmacéutica
• Contact: Cristina Macarrilla
• Phone: +34 932 534 643
• Email: cristina.macarrilla[@]angelinipharma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Controlled Ovarian Stimulation
• In Vitro Fertilization

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital Clínic	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Príncipe de Asturias	Madrid
Spain	Hospital Universitario y Politécnico La Fe	Valencia
Spain	Hospital Clínico Universitario Valladolid	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
Angelini Farmacéutica	Sistemas Genómicos

Country where clinical trial is conducted

Spain, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Genotype of the N312S polymorphism of the LHCGR gene	Genotype of the N312S polymorphism of the LHCGR gene will be tested on blood samples	Through study completion, an average of 1 year