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

GH Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04384744
• Other study ID #: 2019001
• Status: Not yet recruiting
• Start date: May 26, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: April 2020
• Source: Guangzhou First People's Hospital
• Contact: meihong Cai, master
• Phone: 15889936054
• Email: caimhong[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• GH
• Poor Ovarian Reserve Based on POSEIDON

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First People's Hospital

References & Publications (1)

Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number), Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	telomerase activity of granulosa cells	detection of telomerase activity of granulosa cells in wasted follicular fluid	1-2 years
Primary	clinical pregnancy rate	Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred.	1-2 years
Secondary	live birth rate	Live birth rate(%): number of live birth/ transferred cycle.	1-2 years
Secondary	number of oocytes retrieved	number of oocytes retrieved on day of OPU	1-2 years