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Not yet recruitingNCT06754332Updated Mar 12, 2025

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

A Phase 1 interventional study of human chorionic gonadotropin in Premature Ovarian Insufficiency, sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Not yet recruiting. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
20 Years to 39 Years
Sex
Female
01

Study 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, 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.

02

Conditions studied

  • Premature Ovarian Insufficiency

Keywords

  • POI
  • HCG
  • dormant follicles
03

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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."
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • No intervention
    Expectant treatment

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

  • Other
    In vitro fertilization - Embryo transfer

    Embryo vitrification and freezing were performed after fertilization of oocytes.

    Drug: human chorionic gonadotropin

Interventions

  • Drughuman chorionic gonadotropin

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

    Also known as: HCG

05

What researchers measure

Primary outcomes

  1. focilles

    Bilateral ovarian follicles were monitored by ultrasound

    Time frame: Interval of 1-2 weeks after HCG injection

Secondary outcomes

  1. sex hormone

    chemiluminescence method

    Time frame: Interval of 1-2 weeks after HCG injection

  2. Oocyte

    Stereo microscope

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

  3. Embryo

    Stereo microscope

    Time frame: 3-5 days after In vitro fertilization

  4. Pregnancy outcome

    Ultrasonic

    Time frame: One month after embryo transfer

  5. The health of the offspring

    Telephone follow-up

    Time frame: One year after birth

06

Study locations

No study locations are listed for this record.

07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06754332
Lead sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Responsible party
Sponsor
First posted
Dec 31, 2024
Start date
Apr 1, 2025 (estimated)
Primary completion
Apr 1, 2028 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Mar 12, 2025

Study contacts

Xiao Chen, Master
Contact
30395478@qq.com
13868903230
Xiao Chen, Master
principal investigator · The Fourth Affiliated Hospital Zhejiang University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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