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NCT Number: NCT06754332

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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."

Treatment and study plan

Human Chorionic Gonadotropin

Drug

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

Other names: HCG

Primary outcomes

  1. focilles

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

    Bilateral ovarian follicles were monitored by ultrasound

Secondary outcomes

  1. sex hormone

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

    chemiluminescence method

  2. Oocyte

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

    Stereo microscope

  3. Embryo

    Time frame: 3-5 days after In vitro fertilization

    Stereo microscope

  4. Pregnancy outcome

    Time frame: One month after embryo transfer

    Ultrasonic

  5. The health of the offspring

    Time frame: One year after birth

    Telephone follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Chen, Master

CONTACT

[email protected]

13868903230

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study 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).

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Dec 31, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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