Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000636459
Ethics application status
Approved
Date submitted
10/12/2007
Date registered
13/12/2007
Date last updated
13/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gonadotropin-releasing hormone (GnRH) antagonist vs. gonadotropin-releasing hormone agonist protocol for in vitro fertilization in non-obese patients with Polycystic Ovary Syndrome (PCOS). A prospective randomized study.
Scientific title
A prospective randomized study comparing clinical and embryological outcomes in controlled ovarian hyperstimulation protocols with GnRH antagonist and GnRH agonist for in vitro fertilization in PCOS non-obese patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
GnRH antagonists in PCOS 2619 0
Condition category
Condition code
Reproductive Health and Childbirth 2735 2735 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Controlled ovarian hyperstimulation with GnRH antagonists (Cetrotide 0,25 mg/day; intramuscular; starting when the two follices reach the diameter of 14mm untill the criteria for human chorionic gonadotropin administartion) and agonists (Triptorelin 3,75 mg; intramuscular; once, on the 20-22 day of the preceding cycle),
intracytoplasmic sperm injection
Intervention code [1] 2354 0
Treatment: Drugs
Comparator / control treatment
Active group, women stimulated with GnRH agonist in a standard long protocol
Control group
Active

Outcomes
Primary outcome [1] 3624 0
Delivery per attempt, clinical pregnancy per attempt, implantation rate
Timepoint [1] 3624 0
Pregnancy was confirmed by pregnancy test 14 days after embryo transfer (ET) and by vaginal ultrasound scan at 6 and 12 weeks of gestation.
Secondary outcome [1] 6069 0
Matured oocytes (M2) rate, fertilization rate, embryo quality,
Timepoint [1] 6069 0
Fertilizations checked 16-18 hours after intracytoplasmic sperm injection (ICSI)

Eligibility
Key inclusion criteria
1. meeting of 2003 Rotterdam PCOS criteria; 2. age=40 years; 3. body mass index <27 kg/m2; 4. FSH < 12 mIU/ml on the 3rd day of the cycle; 5. negative screening for hepatitis B and C virus infection and human immunodeficiency virus (HIV) infection.
Minimum age
No limit
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
>2 miscarriages, >3 unsuccessful IVF/ICSI cycles, anatomical abnormalities of the uterus on laparoscopy or hysteroscopy and existence of ovarian cysts.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 711 0
Poland
State/province [1] 711 0

Funding & Sponsors
Funding source category [1] 2872 0
Government body
Name [1] 2872 0
State Committee for Scientific Research
Country [1] 2872 0
Poland
Funding source category [2] 2876 0
Government body
Name [2] 2876 0
State Committee for Scientific Research
Country [2] 2876 0
Poland
Primary sponsor type
Government body
Name
State Committee for Scientific Research
Address
1/3 Wspolna Street
Warsaw 00-529 Poland
Country
Poland
Secondary sponsor category [1] 2589 0
University
Name [1] 2589 0
Pomeranian Medical University
Address [1] 2589 0
1 Rybacka Street
Szczecin 70-204 Poland
Country [1] 2589 0
Poland

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Many clinical trials demonstrate that overall outcomes are comparable in GnRH agonists and antagonists protocols. However, recent data suggest that the duration of stimulation as well as the incidence of severe OHSS are significantly reduced in COH protocols with GnRH antagonist. There are only few studies comparing clinical outcome of GnRH agonist and antagonist protocols in PCOS patients. Nevertheless, none of those studies include a detailed embryological description. Because obesity was reported to be associated with relative gonadotropin resistance as well as lower number of collected oocytes we excluded obese patients. Mentioned studies did not consider high BMI as an exclusion criteria.
In the current study, we decided to verify if women with PCOS can also benefit from GnRH antagonist protocol. Additionally, since the relative importance and the role of monitoring of LH in follicular development is still disputable we investigate correlation between LH levels and the treatment outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28236 0
Address 28236 0
Country 28236 0
Phone 28236 0
Fax 28236 0
Email 28236 0
Contact person for public queries
Name 11393 0
Ciepiela Przemyslaw
Address 11393 0
Department of Reproductive Medicine and Gynecology
Pomeranian Medical University
2 Siedlecka Street
Szczecin-Police 72-010
Country 11393 0
Poland
Phone 11393 0
+48 91 4256960
Fax 11393 0
+48 91 4256960
Email 11393 0
[email protected]
Contact person for scientific queries
Name 2321 0
Ciepiela Przemyslaw
Address 2321 0
Department of Reproductive Medicine and Gynecology
Pomeranian Medical University
2 Siedlecka Street
Szczecin-Police 72-010
Country 2321 0
Poland
Phone 2321 0
+48 91 4256960
Fax 2321 0
+48 91 4256960
Email 2321 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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