Comparative Study of Long-acting and Short Acting Triptorelin in PCOS Patients Who Underwent IVF/ICSI

Not Applicable

• Conditions: In Vitro Fertilization; Polycystic Ovary Syndrome
• Interventions: Drug: Long-acting Triptorelin; Drug: Short-acting Triptorelin

• Registration Number: NCT02477566
• Lead Sponsor: Nanjing University

Brief Summary

To test whether long-acting Triptorelin on pituitary down-regulation can improve the clinical pregnancy rate and reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovaries (PCOs) who underwent in vitro fertilization (IVF) or Intracytoplasmic sperm injection

Detailed Description

All patients received standard ovarian stimulation with rFSH under pituitary suppression with GnRH agonist according to a protocol used routinely. The long-acting Triptorelin group use long-acting Triptorelin 1.875mg during the luteal phase on Pituitary down-regulation , the Short acting Triptorelin use short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2\<40pg/ml in serum, was initiated during the luteal phase. Gonadotrophin stimulation of the ovaries was started when serum E2 concentrations declined to \< 40 pg/ml and a vaginal ultrasonographic scan showed an absence of follicles \> 10mm diameter. Ovarian stimulation was started wih 150-250 IU/day of recombinant FSH (Gonal F, Serono, Switzerland); the initial dose was determined by clinical judgement of the clinician according to the patients's age, body mass index, basal FSH and E2. Transvaginal ultrasound and E2 measurement were used to monitor follicular growth, and gonadotropin dosages were adjusted accordingly. Ovulation was triggered by intramuscular administration of 5000-10,000 IU of human chorionic gonadotropin (HCG, Ferring Pharmaceuticals) when at least two follicles reached a diameter of 18 mm. Serum HCG value were measured at 12 h after HCG trigger using the immunoassay. Oocytes were retrieved 36 h after the injection of HCG.

Study Timeline

• Study Start: 2014-12
• Status Verified: 2015-06
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-22
• Last Update Submitted: 2015-06-22
• Study First Posted: 2015-06-23
• Last Update Posted: 2015-06-23
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• PCOS patients diagnosis by Rotterdam Consensus on Diagnostic Criteria who underwent IVF/ICSI treatment

Exclusion Criteria

• Patients with poor ovarian reserve,
• immunological disease,
• endometriosis,
• uterine abnormality,
• endometrium thickness < 8mm before embryo transfer,
• fewer than two good-quality embryos available for transfer or patients with inadequate data for analysis were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long-acting Triptorelin	Long-acting Triptorelin	Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal
Short-acting Triptorelin	Short-acting Triptorelin	Pituitary down-regulation with Short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2\<40pg/ml in serum, was initiated during the luteal phase

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	2 years	compare the cinical pregnancy rate between long-acting and short-acting Triptorelin on pituitary down-regulation in PCOS patients who underwent IVF/ICSI treatment

Secondary Outcome Measures

Name	Time	Method
moderate/severe OHSS rate	2 years	compare the moderate/severe OHSS rate between long-acting and short-acting Triptorelin on pituitary down-regulation in PCOS patients who underwent IVF/ICSI treatment

Trial Locations

Locations (1)

Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower Hospital; 🇨🇳 Nanjing city, Jiangsu, China