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.
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.
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:
- 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.
Exclusion Criteria:
- 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.
Withdrawal criteria:
- Subjects who cannot follow up as scheduled or have poor compliance with the experimental treatment;
- 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.
- Conditions
- Premature Ovarian Insufficiency
- 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 group | Role | What they receive |
|---|---|---|
| Expectant treatment | No intervention | The POl patients undergo transvaginal ultrasound to observe follicular growth every 1-2 weeks, with a monitoring period of 3 months. |
| In vitro fertilization - Embryo transfer | Other | Embryo 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.
focilles
Bilateral ovarian follicles were monitored by ultrasound
Measured: Interval of 1-2 weeks after HCG injection
Secondary outcomes (5)
sex hormone
chemiluminescence method
Measured: Interval of 1-2 weeks after HCG injection
Oocyte
Stereo microscope
Measured: After the egg retrieval operation, the eggs are picked up and observed
Embryo
Stereo microscope
Measured: 3-5 days after In vitro fertilization
Pregnancy outcome
Ultrasonic
Measured: One month after embryo transfer
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.
- First posted31 Dec 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao Chen, Master, Principal investigator, The Fourth Affiliated Hospital Zhejiang University School of Medicine
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 36229897Cha 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 9683349Chian 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06754332
- Acronym / sponsor ID
- KY-2024-242
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- POI, HCG, dormant follicles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Withdrawal criteria:
- Subjects who cannot follow up as scheduled or have poor compliance with the experimental treatment;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expectant treatment | No intervention | –The POl patients undergo transvaginal ultrasound to observe follicular growth every 1-2 weeks, with a monitoring period of 3 months. |
| In vitro fertilization - Embryo transfer | Other | Drug: human chorionic gonadotropinEmbryo vitrification and freezing were performed after fertilization of oocytes. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human chorionic gonadotropinAlso: HCGThe POI patients receive a single intramuscular injection of 10,000 units of human chorionic gonadotropin. | Drug | In vitro fertilization - Embryo transfer |
Primary outcome
focilles
Time frame: Interval of 1-2 weeks after HCG injection
Bilateral ovarian follicles were monitored by ultrasound
5 secondary outcomes
sex hormone
Time frame: Interval of 1-2 weeks after HCG injection
Oocyte
Time frame: After the egg retrieval operation, the eggs are picked up and observed
Embryo
Time frame: 3-5 days after In vitro fertilization
Pregnancy outcome
Time frame: One month after embryo transfer
The health of the offspring
Time frame: One year after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Results publication: PubMed 36229897Xiao 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.
- Results publication: PubMed 9683349Cha 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.
- Results publication: PubMed 37441160Chian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao Chen, Master principal investigator
The Fourth Affiliated Hospital Zhejiang University School of Medicine
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.