Clinical trial NCT04384744: To Explore the Effect of GH on Outcomes of IVF and Telomerase Activity of Granulosa Cells in Women With POR
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: GH
Poor Ovarian Reserve Based on POSEIDON
Keywords: growth hormone
POSEIDON
low ovarian reserve
prospective observational cohort study
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 1-2 years
Secondary outcomes:
measure: live birth rate
timeFrame: 1-2 years
measure: number of oocytes retrieved
timeFrame: 1-2 years
Other outcomes:
measure: telomerase activity of granulosa cells
timeFrame: 1-2 years
Locations:
Study officials:
affiliation: Guangzhou First People's Hospital
name: meihong Cai, master
role: STUDY_DIRECTOR
References:
citation: 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.