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To Explore the Effect of GH on Outcomes of IVF and Telomerase Activity of Granulosa Cells in Women With POR

To Explore the Effect of Growth Hormone on Outcomes of in Vitro Fertilisation and Telomerase Activity of Granulosa Cells in Women With Poor Ovarian Response

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04384744
Enrollment
40
Registered
2020-05-12
Start date
2020-05-26
Completion date
2021-11-30
Last updated
2020-05-21

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

Conditions

GH, Poor Ovarian Reserve Based on POSEIDON

Keywords

growth hormone, POSEIDON, low ovarian reserve, prospective observational cohort study

Brief summary

It is still a big difficult clinical problem for patients with poor ovarian reserve undergoing in vitro fertilization. The decrease in both quality and quantity of egg are the main cause for poor clinical prognosis. Growth hormone (GH) is currently one of the main adjuvant for improving pregnancy outcomes in patients with POR, and the investigators' previous retrospective study suggested GH was effective in live birth rate in subgroup of patients with POR older than 35 years old. To further figure out the mechanism of GH effectiveness in POR patients and the effect on clinical outcomes in POR patients, the investigators designed this prospective observational cohort study.

Interventions

DRUGgrowth hormone

growth hormone was adjuvanted 2IU/d from previous menstrual period for about six weeks.

Sponsors

Guangzhou First People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

For patients with poor ovarian response, the criteria is based on POSEIDON criteria\[1\]: 1. low ovarian reserve(AMH \<1.2ng/ml, or AFC \<5); 2. younger than 40. For patients with normal ovarian reserve, the criteria is as follow: 1. Patients who are between 20-40 years old; 2. clinical diagnosis of non-functional fallopian tube; 3. regular menstrual cycles.

Exclusion criteria

1. BMI ≥28kg/m2; 2. medical diseases such as endocrine and metabolic diseases, autoimmune disease, etc; 3. ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery; 4. adenomyosis or endometriosis confirmed by surgery; 5. untreated abnormal intrauterine environment, such as uterine effusion, endometritis, etc; 6. untreated hydrosalpinx; 7. polycystic ovary syndrome.

Design outcomes

Primary

MeasureTime frameDescription
clinical pregnancy rate1-2 yearsClinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred.

Secondary

MeasureTime frameDescription
live birth rate1-2 yearsLive birth rate(%): number of live birth/ transferred cycle.
number of oocytes retrieved1-2 yearsnumber of oocytes retrieved on day of OPU

Other

MeasureTime frameDescription
telomerase activity of granulosa cells1-2 yearsdetection of telomerase activity of granulosa cells in wasted follicular fluid

Contacts

Primary Contactmeihong Cai, master
caimhong@mail2.sysu.edu.cn15889936054

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026