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Pharmacogenetic Algorithm for Individualized Controlled Ovarian Stimulation

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ClinicalTrials.gov Identifier: NCT03149536
Recruitment Status : Not yet recruiting
First Posted : May 11, 2017
Last Update Posted : February 9, 2018
Sponsor:
Collaborators:
Faculdade de Medicina do ABC
ANDROFERT - Clinica de Andrologia e Reproducao Humana
Information provided by (Responsible Party):
Matheus Roque, Clínica Origen

Brief Summary:
In this study, the investigators will evaluate genetic variation or polymorphisms between individuals submitted to IVF/ICSI cycles, and how these variations influence response to COS and pregnancy outcomes. Thus, this project has the aim to develop a pharmacogenetic algorithm associating gene polymorphisms, the patient clinical information, and functional and hormonal biomarker to: 1) predict the patient response to gonadotropin; 2) develop individualized gonadotropin regimens; 3) improve the accuracy of determining appropriate dosages of gonadotrophins; 4) improve efficacy and patient compliance to COS; and finally 5) reduce the time-to-pregnancy.

Condition or disease Intervention/treatment Phase
Infertility Diagnostic Test: Pharmacogenetic test Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1350 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacogenetic Algorithm for Individualized Controlled Ovarian Stimulation (iCOS) in Assisted Reproductive Technology Cycles
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2020

Arm Intervention/treatment
Active Comparator: Group 1
recombinant FSH starting dose: 100 IU to develop a pharmacogenetic test
Diagnostic Test: Pharmacogenetic test
To develop a pharmacogenetic prediction test

Active Comparator: Group 2
recombinant FSH starting dose: 125 IU to develop a pharmacogenetic test
Diagnostic Test: Pharmacogenetic test
To develop a pharmacogenetic prediction test

Active Comparator: Group 3
recombinant FSH starting dose: 150 IU to develop a pharmacogenetic test
Diagnostic Test: Pharmacogenetic test
To develop a pharmacogenetic prediction test

Active Comparator: Group 4
recombinant FSH starting dose: 175 IU to develop a pharmacogenetic test
Diagnostic Test: Pharmacogenetic test
To develop a pharmacogenetic prediction test

Active Comparator: Group 5
recombinant FSH starting dose: 200 IU to develop a pharmacogenetic test
Diagnostic Test: Pharmacogenetic test
To develop a pharmacogenetic prediction test

Active Comparator: Group 6
recombinant FSH starting dose: 225 IU to develop a pharmacogenetic test
Diagnostic Test: Pharmacogenetic test
To develop a pharmacogenetic prediction test




Primary Outcome Measures :
  1. Number of retrieved oocytes [ Time Frame: It will be assessed on the 22th month after the first patient recruitment ]
    The number of retrieved oocytes during an IVF treatment


Secondary Outcome Measures :
  1. Number of mature oocytes [ Time Frame: It will be assessed on the 22th month after the first patient recruitment ]
    The number of mature during an IVF treatment

  2. Embryo quality - morphological classification [ Time Frame: It will be assessed on the 22th month after the first patient recruitment ]
    Assessment of morphological embryo quality in each group of patients

  3. Ovarian Hyperstimulation Syndrome [ Time Frame: It will be assessed on the 22th month after the first patient recruitment ]
    The incidence of OHSS in each group of patients

  4. Pregnancy Rate [ Time Frame: It will be assessed on the 22th month after the first patient recruitment ]
    The ratio between the number of positive pregnancy blood test and the number of patients submitted to and IVF cycle

  5. Clinical Pregnancy Rate [ Time Frame: It will be assessed on the 22th month after the first patient recruitment ]
    The ratio between the number of patients with at least one gestational sac identified in an ultrasound scan and the number of patients submitted to and IVF cycle

  6. Miscarriage Rate [ Time Frame: It will be assessed on the 22th month after the first patient recruitment ]
    The ratio between ongoing pregnancy and clinical pregnancy

  7. Ongoing Pregnancy Rate [ Time Frame: It will be assessed on the 22th month after the first patient recruitment ]
    The ratio between the number of ongoing pregnancies in 12th week and the number of patients submitted to and IVF cycle

  8. Live Birth Rate [ Time Frame: It will be assessed on the 22th month after the first patient recruitment ]
    The ratio between the number of live birth and the number of patients that started the treatment



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females aged ≤38 years
  • AMH 1.2 ng/mL and AFC 5
  • Normal TSH and prolactin levels
  • The presence of both ovaries without morphological abnormalities
  • Ovulatory cycles with a mean duration between 25-35 days
  • BMI ≤30
  • No evidence of endocrine diseases such as hyperprolactinemia, thyroid dysfunction, or PCOS

Exclusion Criteria:

  • Females aged >38 years
  • PCOS patients
  • Moderate/severe endometriosis (grade III and IV)
  • Previous ovarian surgery
  • Previous radio/chemotherapy
  • Severe male factor infertility (severe oligozoospermia and nonobstructive azoospermia).

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): NCT03149536


Contacts
Contact: Matheus Roque, MD +5521998136052 matheusroque@hotmail.com

Sponsors and Collaborators
Clínica Origen
Faculdade de Medicina do ABC
ANDROFERT - Clinica de Andrologia e Reproducao Humana
Investigators
Principal Investigator: Matheus Roque, MD ORIGEN - Center for Reproductive Medicine

Responsible Party: Matheus Roque, M.D., Clínica Origen
ClinicalTrials.gov Identifier: NCT03149536     History of Changes
Other Study ID Numbers: 64167716.9.1001.0082
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matheus Roque, Clínica Origen:
pharmacogenetic
pharmacogenomic
polymorphism
individualized controlled ovarian stimulation
algorithm
assisted reproduction

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female