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

June 22, 2015 updated by: Li-jun Ding, Nanjing University

Comparative Study of Long-acting and Short Acting Triptorelin on Pituitary Down-regulation in Long Protocol in PCOS Patients Who Underwent IVF/ICSI Treatment

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing city, Jiangsu, China, 210008
        • Recruiting
        • Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long-acting Triptorelin
Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal
Drug: Long-acting Triptorelin
Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal phase
Other Names:
  • Long-acting Triptorelin on pituitary down-regulation
Active Comparator: 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
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
Other Names:
  • Short-acting Triptorelin on pituitary down-regulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
moderate/severe OHSS rate
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BL2014003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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