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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 8 weeks after starting intervention

Awards & highlights

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

Timeline

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks after starting intervention for reporting.

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 • NCT01947907

14%

Anemia

Tooth abcess

Hypothyroidism

Open wound

Blood triglycerides

Strabismus

Bronchitis

100%

80%

60%

40%

20%

Study treatment Arm

ACP-001, Dose-level 2

ACP-001, Dose-level 3

Human Growth Hormone

ACP-001, Dose-level 1

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Center for Human ReproductionLead Sponsor

13 Previous Clinical Trials

1,137 Total Patients Enrolled

Norbert GleicherStudy ChairCenter for Human Reproduction

David H Barad, MDPrincipal InvestigatorCenter for Human Reproduction

1 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?

What questions have other patients asked about this trial?

Does my partner need to come with me?

PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I was advised that I had low egg quality. I would like to try to conceive with my partner but cannot financial afford IVF.

PatientReceived no prior treatments

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.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Human Growth Hormone Pre-treatment for 6 Weeks Prior to Ovulation Induction for IVF

2014. "Human Growth Hormone Pre-treatment for 6 Weeks Prior to Ovulation Induction for IVF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02179255.

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