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

• Conditions: Poor Ovarian Reserve Based on POSEIDON; GH
• Interventions: Drug: growth hormone

• Registration Number: NCT04384744
• Lead Sponsor: Guangzhou First People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21
• Study Start: 2020-05-26
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GH-POR	growth hormone	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.

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	1-2 years	Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred.

Secondary Outcome Measures

Name	Time	Method
number of oocytes retrieved	1-2 years	number of oocytes retrieved on day of OPU
live birth rate	1-2 years	Live birth rate(%): number of live birth/ transferred cycle.