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RecruitingPhase 1

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years to 37 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 investigators will prepare the participants for either a cycle of pulsatile FSH or conventional, daily FSH injection at the identical daily dose of FSH for both conditions."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests FSH, a hormone that helps eggs grow, given in pulses through a vein compared with daily shots at the same daily dose. It is for women who have trouble getting pregnant and have obesity or a low egg supply. Researchers will measure progesterone, a hormone made after an egg is released.

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. This study will also try to rescue the diminished ovarian reserve phenotype in the same fashion. 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have been unable to get pregnant for at least 6 months, with periods every 25–40 days.
  • Have normal thyroid-stimulating hormone (TSH) and prolactin levels.
  • Have a male partner or sperm donor with more than 14 million sperm per milliliter.
  • Have a scan showing at least one open fallopian tube, which carries eggs, and a normal space inside the womb.
  • Agree to delay trying to get pregnant during the first study cycle and to keep a small tube in a vein for treatment.
  • Obesity group: Have a BMI (a weight-to-height measure) of 30–40 and no ongoing weight loss over 1 pound per week for at least 4 weeks before joining.
  • Obesity group: Have no diagnosis of polycystic ovary syndrome (PCOS), proof of egg release, and testosterone levels in the study’s required range. The listing gives the AMH hormone requirement as above 1 or below 8 ng/mL.
  • Low egg supply group: Have a BMI below 30, AMH below 1 ng/mL, and no more than 8 small egg sacs counted in the ovaries. Have at least 2 past treatment cycles canceled because the ovaries did not respond at the highest dose.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    Inclusion Criteria (obseity): * • BMI between 30 kg/m2 and 40 kg/m * Weight stability, i.e. no continued weight loss of \>1lb per week for a minimum of 4 weeks prior to enrollment * Normal thyroid stimulating hormone (TSH) and prolactin * Anti-Mullerian Hormone (AMH) \> 1 ng/ml or \< 8 ng/mL * Willingness to postpone conception for the first study cycle * Involuntary inability to conceive for at least 6 months * No clinical diagnosis of polycystic ovarian syndrome (PCOS) * Documentation of ovulation with luteal progesterone \>6 ng/ml or positive ovulation predictor home testing * Regular menstrual cycles 25-40 days in length * Male partner (or sperm donor) with adequate sperm (\>14 million sperm per ml) * Hysterosalpingogram or saline infusion sonography demonstrating at least one patent Fallopian tube and a normal uterine cavity * Serum total and free testosterone within the 95% CIearance for women with obesity previously studied in our laboratory. * Acceptance of the indwelling catheter and willingness to take part in the study Inclusion criteria (DOR): * BMI less than 30 kg/m2 * Normal TSH and prolactin * Regular menstrual cycles 25-40 days in length * Male partner (or sperm donor) with adequate sperm (\>14M sperm per ml) * Hysterosalpingogram or saline infusion sonography demonstrating at least one patent Fallopian tube and a normal uterine cavity * Anti-Mullerian Hormone (AMH) \< 1.0 ng/ml * Antral follicle count 8 or less * Willingness to postpone conception for the first study cycle * at least 2 prior canceled cycles for lack of response at maximum dose * Involuntary inability to conceive for at least 6 months * Acceptance of the indwelling catheter and willingness to take part in the study

    Study sites (1)

    CO