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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age20-39
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • human chorionic gonadotropin

    Drug

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Expectant treatmentNo intervention 0 interventions
Group B: In vitro fertilization - Embryo transferOther 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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