Hormone Therapy
Human Growth Hormone for Female Infertility
Phase 1 & 2
Waitlist Available
Led By David H Barad, MD
Research Sponsored by Center for Human Reproduction
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The study will be limited to women with Poor Response to prior treatment with evidence of diminished ovarian reserve with 2 or fewer oocytes in a previous ovulation induction cycles with maximal gonadotrophin stimulation. All women in this study will be <45 years old.
Be between 18 and 65 years old
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up8 weeks after starting intervention
Awards & highlights
All Individual Drugs Already Approved
Approved for 30 Other Conditions
No Placebo-Only Group
Study Summary
This trial is testing whether synthetic human growth hormone (HGH) can increase the chances of pregnancy in women with documented diminished ovarian reserve (DOR) by increasing the number of oocytes (eggs).
Eligible Conditions
- Female Infertility
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks after starting intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks after starting intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oocytes retrieved for IVF
Secondary outcome measures
Clinical Pregnancy Rates
Side effects data
From 2015 Phase 2 trial • 53 Patients • NCT0194790717%
Headache
8%
Ear pain
8%
Inguinal hernia
8%
Nausea
8%
Vomiting
8%
Heat exhaustion
8%
Procedural dizziness
8%
Secondary hypothyroidism
8%
Decreased appetite
8%
Nasopharyngitis
8%
Respiratory tract infection
8%
Rhinitis
8%
Hyperthermia
100%
80%
60%
40%
20%
0%
Study treatment Arm
ACP-001, Dose-level 1
ACP-001, Dose-level 2
ACP-001, Dose-level 3
Human Growth Hormone
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Human Growth HormoneExperimental Treatment2 Interventions
1.9 mg (5.7 units) daily injection of Recombinant Human Growth Hormone (HGH) for at least 6 weeks (42 days) plus FSH 450 to 600 units per day administered subcutaneous (SQ) daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger
Group II: Follicle Stimulating HormoneActive Control1 Intervention
FSH 450 to 600 units per day administered SQ daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Water
FDA approved
Follitropin
FDA approved
Find a site
Who is running the clinical trial?
Center for Human ReproductionLead Sponsor
13 Previous Clinical Trials
1,143 Total Patients Enrolled
Norbert GleicherStudy Chair
Center for Human ReproductionDavid H Barad, MDPrincipal Investigator
Center for Human Reproduction1 Previous Clinical Trials
90 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
California
New Jersey
New York
Other
How old are they?
18 - 65
What site did they apply to?
Center for Human Reproduction
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I was diagnosed with infertility approximately six years ago in Kaiser Permanente in Downey, CA. Since then, I tried multiple attempts of insemination that were unsuccessful. One month ago, I attempted IVF at a clinic in Kyiv, Ukraine. Initially, my AMG was 0.40 and after hormonal stimulation a doctor was able to retrieve only two follicles. Then, in one week after the puncture, my doctor said that one follicle was empty and another had an egg but after ICSI it did not divide.
Patient