The Effect of Growth Hormone in Assisted Reproductive Technology Clinical Outcome of Poor Responder

NCT03027843 | Unknown Phase 4 DMC

• 1 other identifier: newivf20170110
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assisted reproduction treatment in patients with low ovarian reserve is a big difficult clinical problem. Growth hormone (GH) is crucial in the development of follicles since preantral follicle to ovulation and can promote steroid hormones and gamete formation, increase the granular cell sensitivity,and inhibition of follicular atresia. Latest research shows that GH can improve egg quality through regulating mitochondrial function of the oocytes and increase the rate of embryo euploid. It becomes a new argument in that promotion of clinical pregnancy rate in assisted reproduction treatment. GH applied in the field of assisted reproduction 30 years experience of applicable people, but drug dosage, drug intervention time continue to explore. 2015 China assisted reproductive stimulate ovulation medicine expert consensus recommend joint GH for poor ovarian response, repeated implantation failure patients and older patients assisted fertility treatment, but not on the specific use time limit, the daily dose of drugs and curative effect. How to maximize growth hormone potential advantage in improving the egg quality bothers the clinical doctors. We had a self-controlled retrospective analyses in growth hormone application and found that the average daily injections of GH dose 2 iu for 45 days can significantly improve the embryo quality in patients with low ovarian reaction. And now long-acting recombinant human growth hormone is available, which make it convenient for patients. A forward-looking experimental is expected to answer clinical practical problems and provide proper GH regimen for low ovarian responder.

Conditions

Low Ovarian Reserve

Keywords

low ovarian reserve; growth hormone; embryo quality; live birth; clinical pregnancy

Outcome Measures

Primary Outcomes (1)

• live birth rate

  Live birth rate(%): number of live birth/ transferred cycle.Compare the live birth rate between the two group with SPSS 20.0.

  1-2year

Secondary Outcomes (6)

• clinical pregnancy rate

  1-2 year

• number of oocytes retrieved

  1-2 year

• fertility rate

  1-2 year

• normal fertility rate

  1-2 year

• transferable embryo rate

  1-2 year

Study Arms (2)

GH group

ACTIVE COMPARATOR

patients in group mini-dose GnRH-a long protocol combine with growth hormone

Drug: Growth Hormone

control group

NO INTERVENTION

patients in group mini-dose GnRH-a long protocol without growth hormone

Interventions

Growth Hormone DRUG

in GH group, patients have weekly injections of GH dose 14 iu, until the day of hCG.

Also known as: somatotropin;GH;somatotrophin;somatotropic

GH group

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women age ≥35 years and ≤40 years.
• ≤ AFC≤6, and AMH level ≥0.5 and≤ 1.1 ng/ml.
• Previous failed transfer cycle ≥2
• Didn't participate in other clinical subjects in three months.
• Written informed consent.

You may not qualify if:

• Body mass index (BMI) ≥25 kg/m2.
• Endocrine metabolic disease, such as diabetes, insulin resistance, hyperthyroidism, Cushing's syndrome, hyperprolactinemia.
• Hypertension (systolic blood pressure ≥140mmHg and diastolic blood pressure≥90mmHg.
• Autoimmune diseases was definitively diagnosed, such as systemic lupus erythematosus, Sjogren's syndrome, Hashimoto's Thyroiditis, multiple sclerosis, rheumatoid arthritis, autoimmune hemolytic anemia, recurrent miscarriage.
• Ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery.
• Complicated with adenomyosis, endometriosis confirmed by surgery, ovarian endometriosis cyst ≥2 cm by ultrasound, all kind of malignant tumors or precancerous disease.
• Untreated hydrosalpinx.
• Eliminate or falls off Criteria:
• Withdraw drug and take appropriate treatment measures if serious adverse events happen during the trial, and subjects will be off.
• Patients that have bad compliance.
• Patients request withdrawal and exit the trial because adverse events occur during the trial.
• No record about treatment.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Related Publications (1)

• Sood A, Mohiyiddeen G, Ahmad G, Fitzgerald C, Watson A, Mohiyiddeen L. Growth hormone for in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD000099. doi: 10.1002/14651858.CD000099.pub4.

  PMID: 34808697 DERIVED

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

• Xing Yang, M.D. & Ph.D.

  The Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Xing Yang, M.D. & Ph.D.

CONTACT

020-38048013; yxing_8358@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 23, 2017
• Study Start: March 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: April 1, 2020
• Last Updated: January 23, 2017

Record last verified: 2017-01