AzTrials
AzTrials

Premature Ovarian InsufficiencyPhase 1NCT06754332

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

A Phase 1 study testing human chorionic gonadotropin in people with Premature Ovarian Insufficiency, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 39 years, women only
Conditions the study is for
Premature Ovarian Insufficiency
What is being tested?
human chorionic gonadotropin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Apr 2025to 31 Aug 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females under 40 years of age with amenorrhea or oligomenorrhea for at least four months, and elevated follicle-stimulating hormone (FSH) levels > 25 IU/l on two separate occasions (with a 4-week interval);
  • 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.

Who cannot join

  • Individuals over 40 years of age, or under 40 years of age with regular menstruation, normal ovulation, amenorrhea or oligomenorrhea for less than 4 months, and elevated follicle-stimulating hormone (FSH) levels < 25 IU/l on two or more separate occasions (with a 4-week interval);
  • 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."

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xiao Chen, Master contact

13868903230

30395478@qq.com

About this study

Official title: The Research on the Role of Human Chorionic Gonadotropin (HCG) Activation in Vivo on the Dormant Follicles in Patients With Premature Ovarian Insufficiency (POI).

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.

Read the detailed description

Inclusion Criteria:

  1. Females under 40 years of age with amenorrhea or oligomenorrhea for at least four months, and elevated follicle-stimulating hormone (FSH) levels > 25 IU/l on two separate occasions (with a 4-week interval);
  2. 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.

Exclusion Criteria:

  1. Individuals over 40 years of age, or under 40 years of age with regular menstruation, normal ovulation, amenorrhea or oligomenorrhea for less than 4 months, and elevated follicle-stimulating hormone (FSH) levels < 25 IU/l on two or more separate occasions (with a 4-week interval);
  2. 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. Patients deemed by the researcher as otherwise unsuitable for participation in this study.

Withdrawal criteria:

  1. Subjects who cannot follow up as scheduled or have poor compliance with the experimental treatment;
  2. Significant safety events occur, and the investigator deems it necessary for the subject to withdraw.Study Method: A total of 60 patients with premature ovarian insufficiency who are planned to undergo in vitro fertilization (IVF) treatment at our hospital were included. Patients were divided into two groups based on their consent to receive HCG injection: the control group (those who did not agree to HCG injection) and the HCG group (those who agreed to HCG injection).

The HCG group received a single intramuscular injection of 10,000 units of HCG. One to two weeks after the injection, transvaginal ultrasound was performed to observe follicular growth, with a monitoring period of 3 months (based on the fact that it takes humans 85 days to develop from a secondary follicle to a mature follicle). If no follicular growth was observed within 3 months, the observation was abandoned. If follicular growth was observed, gonadotropins were used or not used based on follicular development to promote growth or antagonists were used to prevent premature follicular release. When the follicle reached ≥18mm and estradiol reached ≥150pg/ml, recombinant human chorionic gonadotropin (rhCG) 250ug and triptorelin 0.1mg were co-administered to trigger ovulation. Oocyte retrieval was performed 36 hours after triggering. If embryos were obtained, they were cryopreserved for later frozen-thawed embryo transfer (FET) assistance in conception.

The control group underwent transvaginal ultrasound to observe follicular growth every 1-2 weeks, with a monitoring period of 3 months. If no follicular growth was observed within 3 months, the observation was abandoned. If follicular growth was observed, gonadotropins were used or not used based on follicular development to promote growth or antagonists were used to prevent premature follicular release. When the follicle reached ≥18mm and estradiol reached ≥150pg/ml, rhCG 250ug and triptorelin 0.1mg were co-administered to trigger ovulation. Oocyte retrieval was performed 36 hours after triggering. If embryos were obtained, they were cryopreserved for later FET assistance in conception.

Follow-up Plan: ① Within 3 months after HCG administration, patients return to the center every 1-2 weeks for ultrasound and hormone testing, and return to the hospital promptly if any discomfort occurs during this period. ② After embryo transfer and pregnancy, follow-up on the outcome of childbirth, and follow-up on the offspring until one year after birth.

Being tested
human chorionic gonadotropin
Keywords
POI, HCG, dormant follicles
Medical subject headings
Primary Ovarian Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • human chorionic gonadotropinDrug

    Also called HCG

    The POI patients receive a single intramuscular injection of 10,000 units of human chorionic gonadotropin.

Study groups in NCT06754332
Study groupRoleWhat they receive
Expectant treatmentNo interventionThe POl patients undergo transvaginal ultrasound to observe follicular growth every 1-2 weeks, with a monitoring period of 3 months.
In vitro fertilization - Embryo transferOtherEmbryo vitrification and freezing were performed after fertilization of oocytes.
Receives: Drug: human chorionic gonadotropin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. focilles

    Bilateral ovarian follicles were monitored by ultrasound

    Measured: Interval of 1-2 weeks after HCG injection

Secondary outcomes (5)
  1. sex hormone

    chemiluminescence method

    Measured: Interval of 1-2 weeks after HCG injection

  2. Oocyte

    Stereo microscope

    Measured: After the egg retrieval operation, the eggs are picked up and observed

  3. Embryo

    Stereo microscope

    Measured: 3-5 days after In vitro fertilization

  4. Pregnancy outcome

    Ultrasonic

    Measured: One month after embryo transfer

  5. The health of the offspring

    Telephone follow-up

    Measured: One year after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2024
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06754332
Sponsor's protocol ID
KY-2024-242
Status last verified
Mar 2025
First submitted
24 Dec 2024
Last updated
12 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xiao Y, Peng X, Peng Y, Zhang C, Liu W, Yang W, Dou X, Jiang Y, Wang Y, Yang S, Xiang W, Wu T, Li J. Macrophage-derived extracellular vesicles regulate follicular activation and improve ovarian function in old mice by modulating local environment. Clin Transl Med. 2022 Oct;12(10):e1071. doi: 10.1002/ctm2.1071.

    PubMed 36229897
  • Cha KY, Chian RC. Maturation in vitro of immature human oocytes for clinical use. Hum Reprod Update. 1998 Mar-Apr;4(2):103-20. doi: 10.1093/humupd/4.2.103.

    PubMed 9683349
  • Chian RC, Li JH, Lim JH, Yoshida H. IVM of human immature oocytes for infertility treatment and fertility preservation. Reprod Med Biol. 2023 Jul 11;22(1):e12524. doi: 10.1002/rmb2.12524. eCollection 2023 Jan-Dec.

    PubMed 37441160

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing human chorionic gonadotropin in people with Premature Ovarian Insufficiency, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiao Chen, Master (13868903230, 30395478@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

focilles (time frame: Interval of 1-2 weeks after HCG injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06754332, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in