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

NCT04384744 | Unknown

• 1 other identifier: 2019001
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Keywords

growth hormone; POSEIDON; low ovarian reserve; prospective observational cohort study

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

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

  1-2 years

Secondary Outcomes (2)

• live birth rate

  1-2 years

• number of oocytes retrieved

  1-2 years

Other Outcomes (1)

• telomerase activity of granulosa cells

  1-2 years

Study Arms (3)

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.

Drug: growth hormone

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.

NGH-NOR

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

Interventions

growth hormone DRUG

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

GH-POR

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population includes patients diagnosed as POR based on POSEIDON criteria and with low ovairan reserve, as well as patients with normal ovairan reserve seeking for ART help due to pelvic tubal factors.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Related 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 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.

  PMID: 26921622 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

follicular fluid abandoned

MeSH Terms

Interventions

Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• meihong Cai, master

  Guangzhou First People's Hospital

  STUDY DIRECTOR

Central Study Contacts

meihong Cai, master

CONTACT

15889936054; caimhong@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 12, 2020
• Study Start: May 26, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share