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

NCT ID: NCT04384744

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-26
• Study Completion Date: 2021-11-30

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.

Conditions

GH; Poor Ovarian Reserve Based on POSEIDON

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

GH-POR

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.

growth hormone

Intervention Type: DRUG

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

NGH-POR

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

No interventions assigned to this group

NGH-NOR

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

No interventions assigned to this group

Interventions

growth hormone

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou First People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

meihong Cai, master

Role: STUDY_DIRECTOR

Guangzhou First People's Hospital

Central Contacts

meihong Cai, master

Role: CONTACT

caimhong@mail2.sysu.edu.cn

15889936054

References

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 stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.

Reference Type: RESULT

PMID: 26921622 (View on PubMed)

Other Identifiers

2019001

Identifier Type: -

Identifier Source: org_study_id