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

Clinical Observation of Recombinant Human Growth Hormone Injection Assisted in Vitro Fertilization and Embryo Transfer (IVF-ET) in the Treatment of Polycystic Ovary Syndrome (PCOS)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02801565
Enrollment
208
Registered
2016-06-16
Start date
2016-02-29
Completion date
Unknown
Last updated
2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Brief summary

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.

Interventions

DRUGConventional controlled ovarian stimulation proctol

Conventional controlled ovarian stimulation proctol without rhGH.

Sponsors

Peking University Third Hospital
CollaboratorOTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rateOne year
Number of fertilized oocytesOne year

Secondary

MeasureTime frame
Number of retrieved oocytesOne year
Number of high quality embryosOne year
Number of transferred embryosOne year

Countries

China

Contacts

Primary ContactShuo Huang
homelyleaf@aliyun.cn010-82265080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026