InfertilityPhase 1NCT06414096
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
A Phase 1 study testing Follicle Stimulating Hormone in people with Infertility and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Hypothesis: The investigators hypothesize that pulsatile FSH intravenous administration to women with obesity will correct the Reprometabolic Syndrome (RMS) luteal deficiency phenotype. Read more about this study
- Who is it for?
- Ages 19 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Obesity, Diminished Ovarian Reserve (DOR)
- What is being tested?
- Follicle Stimulating Hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to Jan 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
Show all 24Show fewer
- 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
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Asma Giornazi, MS, 303-724-5276, asma.giornazi@cuanschutz.edu
Nanette Santoro, MD
About this study
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.
Read the detailed description
Design: Crossover interventional study. The investigators have selected this design to allow us to compare each woman to herself in consecutive cycles whenever possible.
Methods:
Patient population and protocol: The investigators plan to recruit women with obesity for a proof-of-concept study to demonstrate the potential of this treatment to improve fertility. Before such a treatment would be brought into clinical practice, a more comprehensive program of pre-conceptional care would be desirable to improve the metabolic health of women with obesity and minimize pregnancy complications such as preterm birth and pregnancy related hypertension.
However, that is not the goal of this study which only seeks to identify reproductive hormone and ovarian millieu impact.
Consent/Screening Process: A script for screening participants by telephone who inquire in response to advertisements will be used, which will include the required verbal consent language. Participants who are eligible for enrollment will be asked to come to the Clinical and Translational Research Center (CTRC) for an intake examination and qualifying laboratory tests. At this time, informed consent is obtained by the PI, the Professional Research Assistant, or an Institutional review Board (IRB) approved designee, according to the scripted process. The informed consent discussion is always held in a private room that is free of distractions and participants are allowed the opportunity to ask questions and have their questions answered to their satisfaction before signing the informed consent document. Once informed consent has been provided, procedures are performed as outlined in the procedures section.
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. Participants will be randomized to group A, pulsatile FSH and then conventional daily injected FSH, or group B, conventional FSH and then pulsatile FSH, by the study statistician. Participants will not be blinded to treatment. However, the PI and co-investigator, as well as the research assistant who will perform the assays, will not be expected to be involved in direct care of participants during treatment and will therefore be able to remain blinded to treatment assignment.
To control hormone delivery for both conditions (non-pulsatile FSH vs pulsatile FSH), all participants will receive a Gonadotropin Releasing Hormone (GnRH) antagonist during gonadotropin stimulation and up to the day of Human Chorionic Gonadotropin (HCG) trigger to abolish endogenous gonadotropin production. A baseline ultrasound will be performed within 2 days of the onset of menses to assure that no dominant follicles are present on ovarian ultrasound and E2 is <50 pg/ml prior to initiating stimulation, as per usual clinical practice. The remaining protocol will be administered in the second cycle, after a 1-month 'washout' period to avoid the possibility of carryover.
- Being tested
- Follicle Stimulating Hormone
- Medical subject headings
- Infertility, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follicle Stimulating HormoneDrug
Also called FSH
Pulsatile FSH administration via a portable pump.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Subcutaneous FSH Dosing | Active comparator | A daily gonadotropin dose (typically 75-450 IU) will be assigned and adjusted, based on clinical criteria and, if known, past response to hormones. Recombinant human FSH (rhFSH) will be given as a daily subcutaneous injection, as is performed, by patients at home, in routine clinical practice. Receives: Drug: Follicle Stimulating Hormone |
| Pulsatile IV FSH Dosing | Experimental | participants will receive the same daily rhFSH dose (based on clinical practice criteria); however, it will be delivered via a portable infusion pump with reservoir (Avocet Infusion Pump, Eitan Medical LTD) that will provide an IV bolus (100-500 µl) every 90 minutes, a frequency that has previously been shown to result in physiologic ovulatory cycles in GnRH deficient women (Martin). The total gonadotropin dose delivered over a 24 hour period will be typically 75-450 IU, assigned based on standard of care clinical criteria (max dose is 900IU per clinical care guidelines). Participants will be provided with a 100mL preloaded reservoir, calibrated to deliver the approved standard of care dosing, in 16 boluses (100-500µl) over 24 hours (q 90min), for 7-12 days. Each 100 ml reservoir has capacity for 200 doses if the volume is 500 µl, which is sufficient for the typical 7- 12-day protocol. Receives: Drug: Follicle Stimulating Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Pdg concentration
The primary endpoint of the study is luteal progesterone metabolite (pregnanediol; Pdg) excretion. Luteal Pdg will be compared in the pulsatile FSH cycle to the daily dose subcutaneous (SQ) cycle. Patients who conceive in the cycle of study will not have their conception cycle included in the analysis.
Measured: 4 months
Number of oocytes retrieved
Measured: 4 months
Secondary outcomes (3)
Peak serum estradiol levels
Serum estradiol levels will be measured during monitoring of stimulation cycle and the peak will be determined.
Measured: 4 months
Number of mature follicles
Total number of mature follicles will be recorded during ultrasound monitoring of each stimulation cycle.
Measured: 4 months
Follicle Fluid and Granulosa Cell Protein and Gene Expression
Follicular fluid and granulosa cells will be collected during the retrieval and be analyzed in cell culture and gene expression.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Oct 2024
- Primary completionNov 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Examine effects of pulsatile FSH administration as a new method for stimulation in IVF
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nanette Santoro, MD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414096
- Sponsor's protocol ID
- 23-2564b
- Status last verified
- Oct 2026
- First submitted
- 10 May 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
- ClinicalTrials.gov ID
- NCT06414096
- Acronym / sponsor ID
- 23-2564b
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design: Crossover interventional study. The investigators have selected this design to allow us to compare each woman to herself in consecutive cycles whenever possible.
Methods:
Patient population and protocol: The investigators plan to recruit women with obesity for a proof-of-concept study to demonstrate the potential of this treatment to improve fertility. Before such a treatment would be brought into clinical practice, a more comprehensive program of pre-conceptional care would be desirable to improve the metabolic health of women with obesity and minimize pregnancy complications such as preterm birth and pregnancy related hypertension.
However, that is not the goal of this study which only seeks to identify reproductive hormone and ovarian millieu impact.
Consent/Screening Process: A script for screening participants by telephone who inquire in response to advertisements will be used, which will include the required verbal consent language. Participants who are eligible for enrollment will be asked to come to the Clinical and Translational Research Center (CTRC) for an intake examination and qualifying laboratory tests. At this time, informed consent is obtained by the PI, the Professional Research Assistant, or an Institutional review Board (IRB) approved designee, according to the scripted process. The informed consent discussion is always held in a private room that is free of distractions and participants are allowed the opportunity to ask questions and have their questions answered to their satisfaction before signing the informed consent document. Once informed consent has been provided, procedures are performed as outlined in the procedures section.
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. Participants will be randomized to group A, pulsatile FSH and then conventional daily injected FSH, or group B, conventional FSH and then pulsatile FSH, by the study statistician. Participants will not be blinded to treatment. However, the PI and co-investigator, as well as the research assistant who will perform the assays, will not be expected to be involved in direct care of participants during treatment and will therefore be able to remain blinded to treatment assignment.
To control hormone delivery for both conditions (non-pulsatile FSH vs pulsatile FSH), all participants will receive a Gonadotropin Releasing Hormone (GnRH) antagonist during gonadotropin stimulation and up to the day of Human Chorionic Gonadotropin (HCG) trigger to abolish endogenous gonadotropin production. A baseline ultrasound will be performed within 2 days of the onset of menses to assure that no dominant follicles are present on ovarian ultrasound and E2 is <50 pg/ml prior to initiating stimulation, as per usual clinical practice. The remaining protocol will be administered in the second cycle, after a 1-month 'washout' period to avoid the possibility of carryover.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Examine effects of pulsatile FSH administration as a new method for stimulation in IVF
| Arm | Type | Receives |
|---|---|---|
| Conventional Subcutaneous FSH Dosing | Active comparator | Drug: Follicle Stimulating HormoneA daily gonadotropin dose (typically 75-450 IU) will be assigned and adjusted, based on clinical criteria and, if known, past response to hormones. Recombinant human FSH (rhFSH) will be given as a daily subcutaneous injection, as is performed, by patients at home, in routine clinical practice. |
| Pulsatile IV FSH Dosing | Experimental | Drug: Follicle Stimulating Hormoneparticipants will receive the same daily rhFSH dose (based on clinical practice criteria); however, it will be delivered via a portable infusion pump with reservoir (Avocet Infusion Pump, Eitan Medical LTD) that will provide an IV bolus (100-500 µl) every 90 minutes, a frequency that has previously been shown to result in physiologic ovulatory cycles in GnRH deficient women (Martin). The total gonadotropin dose delivered over a 24 hour period will be typically 75-450 IU, assigned based on standard of care clinical criteria (max dose is 900IU per clinical care guidelines). Participants will be provided with a 100mL preloaded reservoir, calibrated to deliver the approved standard of care dosing, in 16 boluses (100-500µl) over 24 hours (q 90min), for 7-12 days. Each 100 ml reservoir has capacity for 200 doses if the volume is 500 µl, which is sufficient for the typical 7- 12-day protocol. |
Who may qualify
- Ages
- 19 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- • BMI between 30 kg/m2 and 40 kg/m
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follicle Stimulating HormoneAlso: FSHPulsatile FSH administration via a portable pump. | Drug | Conventional Subcutaneous FSH Dosing, Pulsatile IV FSH Dosing |
Primary outcome
Urinary Pdg concentration
Time frame: 4 months
The primary endpoint of the study is luteal progesterone metabolite (pregnanediol; Pdg) excretion. Luteal Pdg will be compared in the pulsatile FSH cycle to the daily dose subcutaneous (SQ) cycle. Patients who conceive in the cycle of study will not have their conception cycle included in the analysis.
Number of oocytes retrieved
Time frame: 4 months
3 secondary outcomes
Peak serum estradiol levels
Time frame: 4 months
Number of mature follicles
Time frame: 4 months
Follicle Fluid and Granulosa Cell Protein and Gene Expression
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Pulsatile gonadotropin administration in in-vitro fertilisationLink provided by the sponsor.
- Estradiol Priming Improves Gonadotrope Sensitivity and Pro-Inflammatory Cytokines in ObesLink provided by the sponsor.
- Acute recapitulation of the hyperinsulinemia and hyperlipidemia characteristic of metabolic syndrome suppresses gonadotropins.Link provided by the sponsor.
- Closed intravenous administration of gonadotropin-releasing hormone: safety of extended peripheral intravenous catheterizationLink provided by the sponsor.
- Effects of pulsatile intravenous follicle- stimulating hormone treatment on ovarian function in women with obesity.Link provided by the sponsor.
- Pulsatile luteinizing hormone amplitude and progesterone metabolite excretion are reduced in obese women.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nanette Santoro, MD principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Follicle Stimulating Hormone in people with Infertility and Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asma Giornazi, MS (303-7245276, asma.giornazi@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Pdg concentration (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.