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The Study of Human Chorionic Gonadotropin (HCG) Activating the Dormant Follicles .

Plain-language guide to NCT06754332: phase 1 non-randomized trial of hCG (human chorionic gonadotropin), 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06754332
Phase
phase 1
Status
not yet recruiting
Start
2025-04-01
Completion (planned or actual)
2028-04-01
Participants
60 (estimated)
Design
non-randomized, open label (everyone knows who gets what), treatment
Conditions studied
Premature Ovarian Insufficiency
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around hCG (human chorionic gonadotropin).

This project aims to activate dormant follicles in patients with premature ovarian insufficiency by injecting human chorionic gonadotropin (hCG) to explore the feasibility of a treatment plan that stimulates the growth of dormant follicles, not visible to the naked eye, to antral follicles visible under ultrasound, without visible follicle growth.

The project also seeks to enable patients to conceive offspring carrying their own genetic material through in vitro fertilization (IVF) technology.

It had two arms (groups): Expectant treatment (no intervention) and In vitro fertilization - Embryo transfer (other).

The POl patients undergo transvaginal ultrasound to observe follicular growth every 1-2 weeks, with a monitoring period of 3 months.

Embryo vitrification and freezing were performed after fertilization of oocytes.

The registry classes the interventions as drug.

More on the Plan

Ultrasound (B-mode) indicating no antral follicle development in both ovaries for at least 3 months prior to study participation; 3.

Those who agree to participate in this study and voluntarily sign the informed consent form.

Those with contraindications to the use of injectable human chorionic gonadotropin (HCG); 3.

Those with asthma, epilepsy, heart disease, migraines, renal impairment, hypertension, or other diseases; 4.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to women only aged from 20 years up to 39 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ultrasound (B-mode) indicating no antral follicle development in both ovaries for at least 3 months prior to study participation;. Those who agree to participate in this study and voluntarily sign the informed consent form.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: those with contraindications to the use of injectable human chorionic gonadotropin (hcg);; those with asthma, epilepsy, heart disease, migraines, renal impairment, hypertension, or other diseases;; patients deemed by the researcher as otherwise unsuitable for participation in this study.".

How the Study Was Run

Design: non-randomized, sequential and open-label.

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the participants and staff both knew the treatment.

It started in 2025-04-01 with completion listed for 2028-04-01.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: focilles (time frame: Interval of 1-2 weeks after HCG injection).

It also tracked 5 secondary outcomes, for example sex hormone, Oocyte, Embryo, Pregnancy outcome and The health of the offspring.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of hCG (human chorionic gonadotropin) in 60 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.

Our Notes on the Compound

hCG (human chorionic gonadotropin): An LH analog that drives Leydig-cell testosterone production.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.