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

October 9, 2019 updated by: Angelini Farmacéutica

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Clinic
        • Contact:
          • Dolors Manau, PhD
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
          • Julio Herrero, PhD
      • Córdoba, Spain
        • Not yet recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
          • Juan Lorente, PhD
      • Granada, Spain
        • Not yet recruiting
        • Hospital Virgen de las Nieves
        • Contact:
          • Luis Martínez, PhD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Laura de la Fuente, PhD
          • Phone Number: +34 917 452 520
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • Miguel Caballero, PhD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Sonia Lobo, PhD
          • Phone Number: +34 917 277 219
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Mª Isabel Calventus, PhD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Príncipe de Asturias
        • Contact:
          • Irene Heras, PhD
      • Valencia, Spain
        • Not yet recruiting
        • Hospital Universitario y Politécnico La Fe
        • Contact:
          • José Mª Rubio, PhD
      • Valladolid, Spain
        • Not yet recruiting
        • Hospital Clinico Universitario Valladolid
        • Contact:
          • Ana Casas, PhD
    • Madrid
      • Alcorcón, Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundacion Alcorcon
        • Contact:
          • Berta Mª Martín, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angelini Farmacéutica

Collaborators

Sistemas Genómicos

Investigators

  • Study Director: María Carrera, PhD, Hospital Universitario 12 de Octubre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2019

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ANG-FOS-2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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