RECRUITING

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Hypothesis: The investigators hypothesize that pulsatile FSH intravenous administration to women with obesity will correct the Reprometabolic Syndrome (RMS) luteal deficiency phenotype. Specific Aim: To test the hypothesis that pulsatile IV administration of FSH will rescue the impaired folliculogenesis and relative hypogonadotropic hypogonadism, characteristic of obesity. The investigators will accomplish this by administering a cycle of pulsatile FSH to women with obesity and comparing their hormone output to a cycle using conventional, daily FSH injection at the identical daily dose. The primary outcome will be luteal phase progesterone excretion.

Official Title

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Quick Facts

Study Start:2024-10-01
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06414096

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.

Ages Eligible for Study:19 Years to 37 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * • BMI between 30 kg/m2 and 40 kg/m
  2. * Weight stability, i.e. no continued weight loss of \>1lb per week for a minimum of 4 weeks prior to enrollment
  3. * Normal thyroid stimulating hormone (TSH) and prolactin
  4. * Anti-Mullerian Hormone (AMH) \> 1 ng/ml or \< 8 ng/mL
  5. * Willingness to postpone conception for the first study cycle
  6. * Involuntary inability to conceive for at least 6 months
  7. * No clinical diagnosis of polycystic ovarian syndrome (PCOS)
  8. * Documentation of ovulation with luteal progesterone \>6 ng/ml or positive ovulation predictor home testing
  9. * Regular menstrual cycles 25-40 days in length
  10. * Male partner (or sperm donor) with adequate sperm (\>14 million sperm per ml)
  11. * Hysterosalpingogram or saline infusion sonography demonstrating at least one patent Fallopian tube and a normal uterine cavity
  12. * Serum total and free testosterone within the 95% CIearance for women with obesity previously studied in our laboratory.
  13. * Acceptance of the indwelling catheter and willingness to take part in the study
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Katherine Kuhn, MS
CONTACT
303-7245276
Katherine.Kuhn@cuanschutz.edu
Asma Giornazi, MS
CONTACT
303-724-5276
Asma.Gioranzi@ucdenver.edu

Principal Investigator

Nanette Santoro, MD
PRINCIPAL_INVESTIGATOR
University of Colorado School of Medicine

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Nanette Santoro, MD, PRINCIPAL_INVESTIGATOR, University of Colorado School of Medicine

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 Registration Dates

Study Start Date2024-10-01
Study Completion Date2026-11

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

  • Infertility
  • Obesity