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

Primary Purpose

In Vitro Fertilization, Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Long-acting Triptorelin
Short-acting Triptorelin
Sponsored by
Nanjing University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for In Vitro Fertilization focused on measuring pcos, Long acting Triptorelin, Short acting Triptorelin, In Vitro Fertilization

Eligibility Criteria

22 Years - 35 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Long-acting Triptorelin

Short-acting Triptorelin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
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

moderate/severe OHSS rate
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

Full Information

First Posted
June 17, 2015
Last Updated
June 22, 2015
Sponsor
Nanjing University
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1. Study Identification

Unique Protocol Identification Number
NCT02477566
Brief Title
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
In Vitro Fertilization, Polycystic Ovary Syndrome
Keywords
pcos, Long acting Triptorelin, Short acting Triptorelin, In Vitro Fertilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long-acting Triptorelin
Arm Type
Experimental
Arm Description
Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal
Arm Title
Short-acting Triptorelin
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Long-acting Triptorelin
Other Intervention Name(s)
Long-acting Triptorelin on pituitary down-regulation
Intervention Description
Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal phase
Intervention Type
Drug
Intervention Name(s)
Short-acting Triptorelin
Other Intervention Name(s)
Short-acting Triptorelin on pituitary down-regulation
Intervention 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
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
compare the cinical pregnancy rate between long-acting and short-acting Triptorelin on pituitary down-regulation in PCOS patients who underwent IVF/ICSI treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
moderate/severe OHSS rate
Description
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
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianjun Zhou, Doctor
Phone
86-25-83304616-70014
Email
zhou6jj@hotmail.com
Facility Information:
Facility Name
Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower Hospital
City
Nanjing city
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianjun Zhou, Dcotor
Phone
86-25-83304616-70014
Email
zhou6jj@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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