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An exploratory clinical trial on the efficacy and safety of recombinant human follicle stimulating hormone+recombinant luteinizing hormone (r-hFSH+r-hLH) in young patients with diminished ovarian reserve (DOR) (POSEIDON Group 3).

An exploratory clinical trial on the efficacy and safety of recombinant human follicle stimulating hormone+recombinant luteinizing hormone (r-hFSH+r-hLH) in young patients with diminished ovarian reserve (DOR) (POSEIDON Group 3).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073995
Enrollment
Unknown
Registered
2023-07-27
Start date
2023-07-27
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

Infertility

Interventions

Group A:From the 3rd day of menstrual cycle, a fixed dose of r-hFSH 300IU (Gonal-F, product of Merck, Germany)+r-hLH 150IU (Luveris, product of Merck, Germany) was injected for ovarian stimulation.
Group B:From the 3rd day of menstrual cycle, a fixed dose of r-hFSH 300IU (Gonal-F, a product of Merck, Germany) was injected for ovarian stimulation.

Sponsors

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

Eligibility

Sex/Gender
Female
Age
20 Years to 34 Years

Inclusion criteria

Inclusion criteria: Subjects meeting Poseidon Group 3 criteria: (1) Age < 35 years old; (2)AFC < 5 or AMH < 1.2 µg /L

Exclusion criteria

Exclusion criteria: (1) Subjects whose previous embryo transfer (ET) failure cycle is = 2; (2) Subjects with a history of repeated pregnancy loss (= 2 miscarriages); (3) Subjects with severe endometriosis (as defined by the American Society of Reproductive Medicine (ASRM) in 1996); (4) Subjects suffering from any disease that cannot tolerate ovarian stimulation, embryo transfer or pregnancy; (5) Subjects with any drug contraindication diseases; (6) Subjects participating in another clinical study at the same time.

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate;

Secondary

MeasureTime frame
Follicular Output Rate;Follicle-To-Oocyte Index;fertilization rate;implantation rate;Biochemical pregnancy rate;Clinical pregnancy rate;Live birth rate;Number of oocytes retrieved;number of MII oocytes;Number of transferrable embryos;Number of high-quality embryos;Number of fresh embryo transfers;Serum LH?estradiol and progesterone Level on HCG Day;Endometrial thickness on embryo transfer day;pregnancy loss;ectopic pregnancy;pregnancy complications;

Countries

China

Contacts

Public ContactDiao Feiyang, Wang Jing

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

wjbonnie@163.com+86 186 5161 8366

Outcome results

None listed

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