← Back to Search

Hormone Therapy

Human Growth Hormone for Diminished Ovarian Reserve

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

Diminished Ovarian Reserve

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 ~ 12 weeks after starting intervention

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

Oropharyngeal pain

Vomiting

Headache

Hypothyroidism

Tooth abcess

Epistaxis

Middle ear inflammation

Iron deficiency anemia

Ear pain

Bronchitis

Nasopharyngitis

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met