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

N

Nanjing University

Status

Unknown

Conditions

In Vitro Fertilization
Polycystic Ovary Syndrome

Treatments

Drug: Long-acting Triptorelin
Drug: Short-acting Triptorelin

Study type

Interventional

Funder types

Other

Identifiers

NCT02477566
BL2014003

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

Female

Ages

22 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups

Long-acting Triptorelin
Experimental group
Description:
Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal
Treatment:
Drug: Long-acting Triptorelin
Short-acting Triptorelin
Active Comparator group
Description:
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
Treatment:
Drug: Short-acting Triptorelin

Trial contacts and locations

0

Loading...

Central trial contact

Jianjun Zhou, Doctor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems