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Clinical Trials/NCT04384744
NCT04384744
Unknown
Not Applicable

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

Guangzhou First People's Hospital0 sites40 target enrollmentMay 26, 2020

Overview

Phase
Not Applicable
Intervention
growth hormone
Conditions
GH
Sponsor
Guangzhou First People's Hospital
Enrollment
40
Primary Endpoint
clinical pregnancy rate
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 26, 2020
End Date
November 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Guangzhou First People's Hospital
Responsible Party
Sponsor

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
  • 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.

Arms & Interventions

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.

Intervention: growth hormone

Outcomes

Primary Outcomes

clinical pregnancy rate

Time Frame: 1-2 years

Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred.

Secondary Outcomes

  • number of oocytes retrieved(1-2 years)
  • live birth rate(1-2 years)

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