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A multicenter, prospective, randomize control study to compare the impact of high purity hMG (HP-HMG) plus recombinant human follicle-stimulating hormone (rFSH) versus mono use of recombinant human follicle-stimulating hormone (rFSH) on HCG day’s progesterone level based on GnRHa long protocol

A multicenter, prospective, randomize control study to compare the impact of high purity hMG (HP-HMG) plus recombinant human follicle-stimulating hormone (rFSH) versus mono use of recombinant human follicle-stimulating hormone (rFSH) on HCG day’s progesterone level based on GnRHa long protocol

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004552
Enrollment
Unknown
Registered
2014-04-21
Start date
2014-04-21
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Infertility

Interventions

A:high purity hMG (HP-HMG) plus recombinant human follicle-stimulating hormone (rFSH)
B:mono use of recombinant human follicle-stimulating hormone (rFSH)

Sponsors

Jiangsu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
22 Years to 37 Years

Inclusion criteria

Inclusion criteria: 1. Aged 20-37 years, regular menstrual cycle (21 to 35 days), assuming ovulation;Medical history of infertility = 1 year;Infertility reasons including: (1) tubal reasons; (2) I / II of endometriosis; (3) male factor; (4) unexplained infertility. 2. First time for patients to be underwent IVF / ICSI treatment; 3. Prior to randomization, BMI: 18-24kg / m2 and weighing 40-80kg; 4. Basic FSH: 6; 8. Agree to sign informed consent form and agree to back to center for follow-up on time.

Exclusion criteria

Exclusion criteria: 1) Polycystic ovary syndrome; 2) Endometriosis of stage III / IV; 3) hyperprolactinemia; 4) Previous IVF / ICSI treatment cycles; 5) Severe systemic disease, endocrine or metabolic abnormalities; 6) Following drugs were used within one month prior to randomization: clomiphene citrate, metformin, gonadotropin or GnRH analogues; 7) Daily use >10 cigarettes within recent 3 months; 8) Alcohol or drug use in recent 12 months; 9) History of chemotherapy (except for treatment of gestational disease) or radiotherapy; 10) Not suitable for pregnancy for the reason such as ovarian, breast, adrenal, pituitary or hypothalamic tumors and genital malformations; 11) Allergic to any experimental drug.

Design outcomes

Primary

MeasureTime frame
progesteron;

Secondary

MeasureTime frame
E2/DHEA/17- hydroxyprogesterone;Total exhaust of Gn, duration of Gn stimulation;Total exhaust of FSH And HP-HMG;Follicle oocytes number with the diameter> 14mm on the trigger day, oocyte retrieval number;Fertilization rate, embryo number, high quality embryo number, frozen embryo number;Implantation rate, biochemical pregnancy rate, clinical pregnancy rate;Cycle cancellation rate,ovarian hyperstimulation rate;

Countries

China

Contacts

Public ContactShu Li

The First Affiliated Hospital of Nanjing Medical University / Jiangsu Provincial Hospital

drshuli@163.com+86 13913834545

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026