Effect of Chinese herbal medicine treatment (Shengjing ointment) on male factor infertility

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200064416

Enrollment

Unknown

Registered

2022-10-07

Start date

2022-10-01

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Male factor infertility

Interventions

Treatment group:Chinese herbal medicine treatment (Shengjing ointment)

Control group:Waitlist

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for couples: (1) Infertility for 12 months or more (primary or secondary); (2) Heterosexual couples; (3) Living together and having regular sexual intercourse. 2. Male inclusion criteria: (1) Aged >= 18 years; (2) At least one abnormal semen parameter in semen analysis in the past 6 months: 1) Sperm concentration 25%; (3) Willingness to provide semen samples at baseline, after 3 months of treatment and after 3 months of follow-up, according to the proposed schedule; (4) Willing to sign written informed consent. 3. Inclusion criteria for women: (1) Aged between 18 and 40; Women over 35 years of age should have normal ovarian reserve (defined as early follicular FSH=1.0 ng/ml, or ovarian sinus follicle count >10); (2) Normal menstrual cycle (defined as 25-35 days of menstrual cycle with signs of ovulation by monitoring basal body temperature, ovulation test paper, or serum progesterone level (>=3ng/ml) in the luteal phase; (3) Evidence of patency of at least one fallopian tube as determined by hysterosalpingography or laparoscopy.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for couples: (1) Previous sterilization procedures (vasectomy, tubal ligation) that may have influenced the results of the study; (2) Assisted reproductive technology is planned in the next 6 months. 2. Exclusion criteria for males: (1) Sperm concentration 35kg/m^2; (4) Currently pregnant; (5) A current serious medical condition such as cancer, heart disease or cirrhosis of the liver; (6) History of systemic chemotherapy or pelvic radiotherapy; (7) The drugs or medications currently in use may affect reproductive function or metabolism.

Design outcomes

Primary

Measure	Time frame
Live birth rate;	—

Secondary

Measure	Time frame
Semen parameters;Conception rate;Pregnancy rate;Pregnancy loss rate;Pregnancy complications;Reproductive hormone;	—

Countries

China

Contacts

Public ContactWu Suzhen

Foshan Fosun Chancheng Hospital

fswszm@163.com+86 13809708102

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026