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A Randomized Controlled Study on the Effect of Natural Plant Extract RECO-18 on Improving Pregnancy in Patients with Poor Ovarian Response

Exploration and Safety Evaluation of Natural Plant Extract RECO-18 in Improving Pregnancy Outcomes

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077287
Enrollment
Unknown
Registered
2023-11-03
Start date
2023-11-08
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

poor ovary response

Interventions

Treatment group:The subjects will be given Reco-18 with dose of 8 capsules/day in 1-5 days of the menstrual cycle, which will be used for two menstrual cycle. In the third Menstrual cycle, subjects wi
Control group:The subjects will be given placebo with dose of 8 capsules/day in 1-5 days of the menstrual cycle, which will be used for two menstrual cycles. In the third Menstrual cycle, subjects wil

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age : 20 = Age = 40 years old; 2. Women in the first or second IVF/ICSI cycle; 3. BMI = 25Kg/m2; 4. Meeting with IVF/ICSI indications for assisted pregnancy; 5. Meeting with POSEIDON criteria (1:Age<35 years old, AFC= 5 or AMH= 1.2 ng/mL, and = 9 eggs taken in the previous cycle; 2: Age = 35, AFC = 5 or AMH = 1.2 ng/mL, with = 9 eggs retrieved in the previous cycle; 3: Age<35 years old, AFC<5 or AMH<1.2 ng/mL; 4: Age = 35, AFC<5 or AMH<1.2 ng/mL)

Exclusion criteria

Exclusion criteria: 1. Recurrent implantation failure (3 or more embryo transfer cycles failure in the past); 2. Moderate and severe endometriosis or adenomyosis; 3. Untreated hydrosalpinx; 4. Untreated uterine adhesions or submucosal fibroids; 5. The patient is currently not suitable for ART-assisted pregnancy or is associated with diseases that are not suitable for pregnancy; 6. Chromosome abnormalities (excluding polymorphisms) in both spouses; 7. Participated in clinical trials of other drugs within one month prior to enrollment; 8. There are other uncontrolled endocrine diseases that affect hormone secretion and metabolism (such as hyperthyroidism, hypothyroidism, adrenal diseases, obesity, etc.);

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate;

Secondary

MeasureTime frame
Number of retrieved oocytes;High quality embryo rate;Biochemical pregnancy rate;Embryo implantation rate;Miscarriage rate;

Countries

China

Contacts

Public ContactQun Lu

Beijing Chao-Yang Hospital, Capital Medical University

luqun1023@sina.com+86 131 6424 2297

Outcome results

None listed

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