Clinical Evaluation of Integrated Chinese-Western Medicine for Infertility With DOR Patients in Women Achieving Natural Pregnancy

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 3

Conditions: Infertility; Diminished Ovarian Reserve (DOR)

Treatments: Drug: Placebo; Drug: Traditional Chinese Medicine; Drug: Western Medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT07296614

K9220

Details and patient eligibility

About

This study aims to evaluate the superiority of an integrated traditional Chinese and Western medicine regimen ("Xiehe DOR Bushen Tongzhi Formula" + ovulation induction therapy with ovulation monitoring and timed intercourse) compared to standard treatment alone (placebo + ovulation induction therapy with ovulation monitoring and timed intercourse) in improving the natural cumulative clinical pregnancy rate in infertile patients with kidney deficiency-type diminished ovarian reserve (DOR).

Enrollment: 320 estimated patients

Sex: Female

Ages: 22 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female patients aged 22 to 39 years (inclusive).
2. Meet the diagnostic criteria for diminished ovarian reserve (requiring at least two of the following: Basal FSH 10-25 IU/L; AMH < 1.1 ng/mL; AFC < 7) and infertility(defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse).
3. Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine
4. Voluntarily participate in this study and provide written informed consent.

Exclusion criteria

1. Patients with premature ovarian insufficiency or premature ovarian failure (basal FSH >25 IU/L), organic pathologies such as ovarian tumors, endometrial tuberculosis, intrauterine adhesions, or endometrial injuries, as well as those with congenital adrenal hyperplasia or Cushing's syndrome;
2. Infertility caused by organic lesions of the fallopian tubes, uterus, cervix, etc.
3. Infertility due to male factors (based on semen analysis reports, meeting the diagnostic criteria for oligoasthenoteratozoospermia according to the WHO 5th edition standards).
4. DOR caused by iatrogenic factors (such as pelvic surgery, radiotherapy/chemotherapy, uterine artery embolization, etc.).
5. Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders.
6. Individuals with known allergies to the investigational drug or its components.
7. Use of hormonal medications (e.g., estrogen, contraceptive drugs) within one month prior to enrollment, or use of kidney-tonifying Chinese herbal medicines or proprietary Chinese medicinal products within one month prior to enrollment.
8. Patients currently participating in or planning to participate in other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 2 patient groups, including a placebo group

Western medicine group

Placebo Comparator group

Description:

Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo.

Treatment:

Drug: Western Medicine

Drug: Placebo

Integrated traditional Chinese and Western medicine

Experimental group

Description:

Take the "Xiehe DOR Kidney-Tonifying Universal Formula" orally for three months; thereafter, continue the Chinese herbal formula while combining it with three cycles of letrozole.

Treatment:

Drug: Western Medicine

Drug: Traditional Chinese Medicine