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

NCT ID: NCT02477566

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31

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.

Conditions

In Vitro Fertilization; Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Long-acting Triptorelin

Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal

Group Type: EXPERIMENTAL

Long-acting Triptorelin

Intervention Type: DRUG

Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal phase

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

Group Type: ACTIVE_COMPARATOR

Short-acting Triptorelin

Intervention Type: DRUG

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

Interventions

Long-acting Triptorelin

Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal phase

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Long-acting Triptorelin on pituitary down-regulation; Short-acting Triptorelin on pituitary down-regulation

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing University

OTHER

Sponsor Role: lead

Responsible Party

Li-jun Ding

Reproductive Medicine Center, Drum Tower Hospital Affiliated to Nanjing University Medical College

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianjun Zhou, Doctor

Role: CONTACT

zhou6jj@hotmail.com

86-25-83304616-70014

Facility Contacts

Jianjun Zhou, Dcotor

Role: primary

zhou6jj@hotmail.com

86-25-83304616-70014

Other Identifiers

BL2014003

Identifier Type: -

Identifier Source: org_study_id