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

Guangzhou First People's Hospital

Status: Unknown

Conditions: GH; Poor Ovarian Reserve Based on POSEIDON

Treatments: Drug: growth hormone

Study type: Observational

Funder types: Other

Identifiers

NCT04384744

2019001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 3 patient groups

GH-POR

Description:

Participants diagnosed POR according to POSEIDON criteria with low ovarian reserve undergo IVF in our center with long protocol or antagonist protocol and is adjuvant with GH 2IU/d from previous menstrual period for about six weeks.

Treatment:

Drug: growth hormone

NGH-POR

Description:

Participants diagnosed POR according to POSEIDON criteria with low reserve undergo IVF in our center with long protocol or antagonist protocol without GH adjuvant.

NGH-NOR

Description:

Participants with normal ovarian reserve undergo IVF in our center with long protocol or antagonist protocol without GH adjuvant.