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Evaluating the efficacy and safety of the medical recombinant collagen care solution on endometrial thickness and clinical pregnancy rates in patients with refractory thin endometrium: a single-arm, self-controlled clinical study

Evaluating the efficacy and safety of the medical recombinant collagen care solution on endometrial thickness and clinical pregnancy rates in patients with refractory thin endometrium: a single-arm, self-controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098571
Enrollment
Unknown
Registered
2025-03-11
Start date
2025-09-08
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Refractory thin endometrium

Interventions

Experimental Group:Medical Recombinant Collagen Treatment Solution

Sponsors

The Third Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.The age range is 20 to 40 years; 2.Body mass index (BMI) 18.5-24.9 kg/m^2; 3.Failed embryo transfer at our center during the previous cycle (within six months) with endometrial thickness data; 4.There is >= 1 transferable good quality frozen embryo; 5.Endometrial thickness <6mm after standardized treatment or after standard therapy; 6.Agree to the study protocol and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with uterine and endometrial lesions, including submucosal uterine fibroids, intramural uterine fibroids larger than 5cm or less than 5cm but affecting the morphology of the uterine cavity, endometrial polyps > 1cm, and intrauterine adhesions that affect pregnancy as assessed by the investigator; 2. Presence of hydrosalpinx visible on ultrasound that may affect pregnancy; 3. Previous surgery to confirm ASRM stage III~IV endometriosis; 4. Have recurrent miscarriage; 5. Uterine malformations, such as double uterus, unicornuate uterus, mediastinal uterus and other abnormalities; 6. Suffering from malignant tumors, such as breast cancer, ovarian cancer, cervical cancer, etc.; 7. Patients with major systemic diseases, endocrine or metabolic abnormalities (excluding controlled thyroid gland function diseases); 8. Patients with thromboembolic disease or previous history of thromboembolic disease; 9. Allergic constitution, including a known history of allergy to any ingredient in the investigational product (e.g., type III collagen).

Design outcomes

Primary

MeasureTime frame
Endometrial thickness;

Secondary

MeasureTime frame
Implantation rate;Clinical pregnancy rate;live birth rate;Fetal malformation rate;Pregnancy loss rate;Adverse event rate;

Countries

China

Contacts

Public ContactLi Li

The Third Affiliated Hospital of Guangzhou Medical University

lili77191212@163.com+86 20 81292233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026