Hormone replacement for adolescents with premature ovarian insufficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial enrolls female adolescents aged 11–19 with premature ovarian insufficiency and a group of healthy female volunteers for comparison. Participants receive hormone replacement therapy (estrogen patch with progesterone) and attend clinic visits every six months for two years with blood and urine tests, cardiovascular and vascular stiffness testing, and imaging. Primary outcomes focus on bone health including central and peripheral bone mineral density by DXA, vertebral fracture assessment, body composition, and correlation with phenotype and genotype; secondary outcomes include bone microarchitecture by HR-pQCT, metabolic panels, lipid profiles, insulin resistance, muscle strength, and other cardiovascular measures. All testing and imaging are conducted at the NIH Clinical Center with pre- and post-treatment comparisons over the follow-up period.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

Inclusion Criteria for POI Participants

To be eligible to participate in this study, an individual must meet all the following criteria:

1. Individuals aged 11-19 years, inclusive, at the time of enrollment.
2. Diagnosis of premature ovarian insufficiency.
3. Documentation of one elevated serum FSH measurement greater than the testing laboratory's upper reference range (for age/Tanner stage).
4. Identify as female (i.e., sex assigned at birth)
5. Negative pregnancy test.

Inclusion Criteria for Healthy Volunteers:

1. Individuals aged 11-19 years.
2. Identify as female (i.e., sex assigned at birth)
3. Negative pregnancy test.
4. Absence of known chronic disease

EXCLUSION CRITERIA:

Male participants are excluded from both study groups (POI and Healthy Volunteers) as POI affects only the female reproductive system, while pregnant participants are not eligible to have DXA or HRpQCT imaging for safety reasons.

Exclusion Criteria for POI participants:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. POI in the setting of Turner syndrome.
2. Patients who screened positive for celiac disease.
3. Receipt of any medications including HRT determined by the investigator to affect bone metabolism 3 months prior to enrollment.
4. Any medical condition determined by the investigator to affect bone health will be excluded.
5. Presence of a medical, psychiatric, or social condition which, in the opinion of the investigator, would place undue burden on the subject, NIH resources, or increase risk of participation.
6. Report of sexual activity but refusal to use a copper intrauterine device or double barrier forms of contraception during the study.

Exclusion Criteria for Healthy Volunteers:

For healthy volunteers, all exclusion criteria will apply as for POI participants except for number 1.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Catherine M Gordon, M.D. — Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Study coordinator: Catherine M Gordon, M.D.
• Email: catherine.gordon@nih.gov
• Phone: (301) 827-5449

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Autologous Hair Follicle Secretome + PRP for POI

  This pilot study tests whether a patient’s own hair follicle secretome combined with their own platelet-rich plasma can improve ovarian function in women with premature ovarian insufficiency.

  Recruiting Phase 2 Trio Fertility · Toronto, Ontario · NCT07916740

• Intravenous hUC-MSCs for POI: Safety, Tolerability and Early Efficacy

  We’re testing whether IV human umbilical cord mesenchymal stem cells can be safely given to women under 40 with premature ovarian insufficiency to see if it helps improve ovarian function.

  Recruiting Phase 1/2 Shenzhen Wingor Biotechnology Co., Ltd. · Beijing, Beijing Municipality · NCT07775391

• Human amniotic mesenchymal stem cell treatment for premature ovarian insufficiency

  This trial will test whether an intravenous infusion of human amniotic mesenchymal stem cells combined with standard hormone therapy can help women under 40 with premature ovarian insufficiency.

  Recruiting Phase 1/2 Changhai Hospital · Shanghai · NCT07115082

• Using Platelet-rich Plasma to Improve Female Fertility

  This study is testing whether injections of platelet-rich plasma can help improve fertility in women dealing with issues like poor ovarian response and repeated implantation failure.

  Recruiting The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Yiwu, Zhejiang · NCT06645379

• Using fat-derived cells to treat premature ovarian insufficiency

  This study is testing if using fat-derived cells can help improve pregnancy chances for women with premature ovarian insufficiency compared to standard IVF treatments.

  Recruiting Peking University Third Hospital · Beijing, Beijing Municipality · NCT06481969

• Examining the link between ovarian function and serum biomarkers

  This study is trying to see how blood markers differ between healthy women and those with ovarian issues to better understand their connection.

  Recruiting Dongzhimen Hospital, Beijing · Beijing · NCT06096766

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.