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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
GH, Poor Ovarian Reserve Based on POSEIDON

Intervention / Treatment
-----------------
* Drug: growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For patients with poor ovarian response, the criteria is based on POSEIDON criteria[1]: low ovarian reserve(AMH <1.2ng/ml, or AFC <5); younger than 40. For patients with normal ovarian reserve, the criteria is as follow: Patients who are between 20-40 years old; clinical diagnosis of non-functional fallopian tube; regular menstrual cycles. Exclusion Criteria: BMI ≥28kg/m2; medical diseases such as endocrine and metabolic diseases, autoimmune disease, etc; ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery; adenomyosis or endometriosis confirmed by surgery; untreated abnormal intrauterine environment, such as uterine effusion, endometritis, etc; untreated hydrosalpinx; polycystic ovary syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GH-POR<br>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. | Drug: growth hormone<br>* growth hormone was adjuvanted 2IU/d from previous menstrual period for about six weeks.<br>|
| NGH-POR<br>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<br>Participants with normal ovarian reserve undergo IVF in our center with long protocol or antagonist protocol without GH adjuvant. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred. | 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | Live birth rate(%): number of live birth/ transferred cycle. | 1-2 years | 
| number of oocytes retrieved | number of oocytes retrieved on day of OPU | 1-2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
growth hormone, POSEIDON, low ovarian reserve, prospective observational cohort study