Comparison Between Testosterone and Estradiol Over the Homogenization of Follicular Cohort

NCT03238092 | Unknown Phase 3

• 1 other identifier: 67491417800005327
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

In vitro fertilization(IVF) with Gonadotropin-releasing hormone (GnRH) antagonist is one of the most used protocol for the treatment of infertile couples nowadays. Despite several advantages over GnRH agonist, the antagonist may be associated with a slightly reduction in pregnancy rates. Several medications have been tested in order to increase ovarian response to ovulation induction, including estradiol and testosterone. A clinical trial in women with IVF indication will be performed and this women will be randomly assigned to receive topic testosterone, oral estradiol or no pre-treatment prior to IVF with human Chorionic Gonadotropin (hMG) and GnRH antagonist. The primary endpoint will be the size and number of follicles on the beginning of the cycle, after pre-treatment.

Conditions

Fertility Disorders

Keywords

in vitro fertilization; estradiol; gnrh antagonist; testosterone

Outcome Measures

Primary Outcomes (1)

• number of antral follicles

  Number of follicles measured by transvaginal ultrasound during the first or second day after menstruation

  15 days after intervention

Secondary Outcomes (5)

• follicular cohort homogeneity

  15 days after intervention

• metaphase II oocytes

  30 days

• gonadotrophin use

  30 days

• number of embryos

  30 days

• pregnancy

  6 weeks

Study Arms (3)

Estradiol group

ACTIVE COMPARATOR

In the late luteal phase, the participant will receive estradiol 2mg and will take orally a total of 4mg per day (2mg in the morning and 2 mg in the night) until the next menstrual bleeding. After that, the patient will descontinue the medication and proceed to the regular in vitro fertilization protocol.

Drug: Estradiol

Control group

NO INTERVENTION

No pre-treatment will be administrated. The regular in vitro fertilization protocol will be performed.

Testosterone group

EXPERIMENTAL

Testosterone 25mg (10mg/g) transdermal during the late luteal phase, until the next menstrual bleeding.

Drug: Testosterone

Interventions

Testosterone DRUG

testosterone gel daily during the late luteal phase.

Also known as: androgel

Testosterone group

Estradiol DRUG

oral estradiol during the late luteal phase.

Also known as: estradiol valerato

Estradiol group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Regular cycles (between 25-34 days)
• In vitro fertilization indication for male cause, unexplained infertility or tubal factor
• Both ovaries
• Thyroid-stimulating hormone(TSH) \< 2,5 mU/L
• Anti-Müllerian hormone (AMH) between 1-5 ng/ml
• Body Mass Index (BMI) \< 30

You may not qualify if:

• Ovarian surgery
• Endometriosis
• Endocrinology or metabolic disorder
• Polycystic ovary syndrome (PCOS)
• Poor Ovarian Response (according to Bologna criteria)

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Interventions

Testosterone; Estradiol

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrenes; Estranes; Estradiol Congeners

Study Officials

• João Sabino, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camila Bessow, MD

CONTACT

+5551992723620; k.bessow@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: As a pre-treatment for in vitro fertilization, one arm will receive transdermic testosterone , one arm will receive oral estradiol and a third arm will be the control group, without pre-treatment

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: August 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 3, 2017

Record last verified: 2017-08