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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after starting intervention
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial tests if starting synthetic human growth hormone (HGH) before IVF can help women with poor ovarian response produce more and better-quality eggs. The study focuses on women under 45 who have had limited success with previous treatments. HGH may improve egg development by boosting growth factors in the ovaries. Growth hormone (GH) has been explored in various studies to improve outcomes in women undergoing in vitro fertilization (IVF), particularly for those with diminished ovarian reserve or poor response to previous treatments.

Eligible Conditions
  • Female Infertility

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after starting intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after starting intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Clinical Pregnancy Rates

Side effects data

From 2015 Phase 2 trial • 53 Patients • NCT01947907
23%
Pyrexia
8%
Oropharyngeal pain
8%
Vomiting
8%
Headache
8%
Hypothyroidism
8%
Tooth abcess
8%
Epistaxis
8%
Middle ear inflammation
8%
Iron deficiency anemia
8%
Ear pain
8%
Bronchitis
8%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Human Growth Hormone
ACP-001, Dose-level 2
ACP-001, Dose-level 3
ACP-001, Dose-level 1

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 5 Other Conditions
This treatment demonstrated efficacy for 5 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
Somatotropin
FDA approved
Urofollitropin
FDA approved

Find a Location

Who is running the clinical trial?

Center for Human ReproductionLead Sponsor
13 Previous Clinical Trials
1,137 Total Patients Enrolled
David H Barad, MDPrincipal InvestigatorCenter for Human Reproduction
1 Previous Clinical Trials
90 Total Patients Enrolled
Norbert GleicherStudy ChairCenter for Human Reproduction
~3 spots leftby Oct 2025
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