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

NCT06754332 | Not Yet Recruiting Phase 1

• 1 other identifier: KY-2024-242
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Premature Ovarian Insufficiency

Keywords

POI; HCG; dormant follicles

Outcome Measures

Primary Outcomes (1)

• focilles

  Bilateral ovarian follicles were monitored by ultrasound

  Interval of 1-2 weeks after HCG injection

Secondary Outcomes (5)

• sex hormone

  Interval of 1-2 weeks after HCG injection

• Oocyte

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

• Embryo

  3-5 days after In vitro fertilization

• Pregnancy outcome

  One month after embryo transfer

• The health of the offspring

  One year after birth

Study Arms (2)

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.

Drug: human chorionic gonadotropin

Interventions

human chorionic gonadotropin DRUG

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

Also known as: HCG

In vitro fertilization - Embryo transfer

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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."

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Related Publications (3)

• 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.

  PMID: 36229897 RESULT

• 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.

  PMID: 9683349 RESULT

• 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.

  PMID: 37441160 RESULT

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Xiao Chen, Master

  The Fourth Affiliated Hospital Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Chen, Master

CONTACT

13868903230; 30395478@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: December 31, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share