Clinical trial NCT02477566: Comparative Study of Long-acting and Short Acting Triptorelin in PCOS Patients Who Underwent IVF/ICSI
Official title: Comparative Study of Long-acting and Short Acting Triptorelin on Pituitary Down-regulation in Long Protocol in PCOS Patients Who Underwent IVF/ICSI Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: In Vitro Fertilization
Polycystic Ovary Syndrome
Keywords: pcos
Long acting Triptorelin
Short acting Triptorelin
In Vitro Fertilization
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 2 years
Secondary outcomes:
measure: moderate/severe OHSS rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing city
country: China
facility: Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower Hospital
state: Jiangsu
Study officials:
References: