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Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS

G

GeneScience Pharmaceuticals (GenSci)

Status

Unknown

Conditions

Polycystic Ovary Syndrome

Treatments

Drug: Conventional controlled ovarian stimulation proctol

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02801565
GenSci GH AQ CT-PCOS

Details and patient eligibility

About

Observe validity of Recombinant Human Growth Hormone Injection assisted in IVF-ET (in vitro fertilization and embryo transfer) treatment of PCOS (polycystic ovary syndrome) patients.

Enrollment

208 estimated patients

Sex

Female

Ages

25 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 25 and 35 years old, married female and infertile.
  • BMI≥25kg/m2.
  • Diagnosed as PCOS.
  • No obvious chronic organic diseases, such as liver, kidney, heart, lung, thyroid, adrenal disease.
  • Subjects do not take part in other clinical trial study within 3 months.
  • The subjects sign the informed consent form.

Exclusion criteria

  • BMI<25kg/m2.
  • Hyperprolactinemia and congenital adrenal cortical hyperplasia.
  • Diabetes, thyroid function hyperthyroidism, thyroid dysfunction, cushing's syndrome.
  • Pelvic and peritoneal tumor and tumor secreting hyperandrogenism.
  • Severe acute and chronic liver and kidney disease, such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity.
  • Liver and kidney dysfunction, AST/ALT is 2.5 times higher than the normal limit, the serum of creatinine is 2 times higher than the normal level.
  • Diseases affecting outcome of IVF pregnancy, eg, hydrosalpinx, hysteromyoma>4 cm, adenomyosis, endometriosis, endometrial cyst of ovary, unilateral ovary, tuberculosis of reproductive system.
  • Allergic to E. coli. expression product and its excipients.
  • Being involved in other drug clinical researchers.
  • The researchers consider who is not suitable for the group.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

208 participants in 1 patient group

GH AQ
Experimental group
Description:
Controlled ovarian stimulation in the middle of the corpus (D21 days) of the previous menstrual cycle to use recombinant Human Growth Hormone Injection(rhGH) Injection 15IU/5mg/3mL/cartridge, 5IU per day, Subcutaneous injection after 20:00 until the HCG trigger day.
Treatment:
Drug: Conventional controlled ovarian stimulation proctol

Trial contacts and locations

1

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Central trial contact

Shuo Huang

Data sourced from clinicaltrials.gov

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