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Multi-center study of establishing female AMH reference range and COS response cut-off value in reproductive center

Multi-center study of establishing female AMH reference range and COS response cut-off value in reproductive center

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200057120
Enrollment
Unknown
Registered
2022-02-28
Start date
2022-03-31
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility

Interventions

None listed

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Group A: (1) Age 20-50 years old; (2) The normal menstrual cycle of women of childbearing age: 24-35 days; the normal menstrual cycle of perimenopausal women in the past 10 years; (3) Normal BMI range: 18.5-24.9 (WHO standard). 2. Group B: (1) Infertility patients require IVF or ICSI; (2) Have normal bilateral ovaries; (3) Receive IVF/ICSI cycle for the first time; (4) Accept the controlled ovarian stimulation (COS) of r-FSH with the agonist luteal phase short-acting and long-term regimen, with a starting dose of 100 IU-300 IU (the starting dose is adjusted according to AFC, see below for details) or receiving The down-regulation regimen is an antagonist regimen, a fixed dose (150 - 300IU) of r-FSH for controlled ovarian stimulation (COS).

Exclusion criteria

Exclusion criteria: 1. Group A: (1) Pregnancy; (2) According to ultrasound examination, it is found that the developmental abnormalities of the accessory mesonephros such as: congenital absence of vagina (MRKH syndrome); congenital absence of uterus and primordial uterus; naive uterus; unicornuate uterus and residual horn uterus; double uterus and double horns uterus; arcuate uterus; (3) After ultrasound examination, it is found that there are abnormalities of the ovary, such as endometriosis cyst, PCOS, etc; (4) POI patients; (5) Medical history through consultation: endocrine or metabolic abnormalities (ie type I or type II diabetes, or pituitary, adrenal gland, pancreas, thyroid, liver or kidney disease); (6) Medical history through consultation: autoimmune diseases, such as SLE, Sjogrens syndrome, etc; (7) Past history of systemic and pelvic local radiotherapy and chemotherapy; (8) Through consultation, it is found that there is a family genetic history, a history of chromosomal abnormalities, reproductive system tuberculosis, reproductive system tumors and other diseases; (9) Past history of ovarian surgery; (10) The history of hormone therapy in the first 3 months (hormonal contraceptives, gonadotropin releasing hormone [GnRH], FSH); (11) Smoking history; 2. Group B: (1) There are contraindications to the use of r-FSH; (2) Use urinary gonadotropin (HMG); (3) Use clomiphene, letrozole and other micro-stimulation programs that have potential effects on estrogen; (4) Pretreatment with other hormones (growth hormone; contraceptives and androgens, etc.); (5) Have a history of ovarian surgery; (6) History of cytotoxic drugs or pelvic radiotherapy and chemotherapy.

Design outcomes

Primary

MeasureTime frame
Anti-Mullerian hormone;Antral Follicle Count;Number of retrieved follicles;Subject operating characteristic curve;

Countries

China

Contacts

Public ContactYingpu Sun

The First Affiliated Hospital of Zhengzhou University

syp2008@vip.sina.com+86 15981978863

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026