NCT03989024

Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: Female
• Age: 24 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Polycystic ovary syndrome (PCOS) patients are often accompanied by infertility. Non-obese PCOS infertility is more difficult to treat than obese PCOS. The study included non-obese PCOS patients who had not recovered from regular menstruation after six months of metformin treatment. Half of the patients were treated with clomiphene for ovulation induction and half with GnRH pulse therapy.

Detailed description

To investigate whether GnRH pulse therapy of non-obese PCOS women can improve ovulation rate.The investigators plan to recruit non-obese PCOS women with abnormal GnRH pulse mode not effective of metformin treatment at childbearing age. By using GnRH pulse therapy and Clomiphene therapy. the investigators will intervent the participants for 3 months and to compare outcome in each group.

Conditions

• Polycystic Ovary Syndrome
• Infertility
• Ovulation Disorder

Interventions

Type	Name	Description
DRUG	Gonadorelin	Drug: Gonadotropin-releasing Hormone. Generic name: Gonadorelin. Dosage form: 600ug. Dosage: 10ug/puls. Frequency: every 90 min. Duration: 3 months
DRUG	Clomiphene	Drug: Clomiphene. Generic name: Clomiphene. Dosage form: 50mg. Dosage: 50mg. Frequency: once a day. Duration: 3 months

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-12-30
• Completion: 2021-12-30
• First posted: 2019-06-18
• Last updated: 2019-06-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study