Contact information
Type
Scientific
Primary contact
Dr Hwang Jiann-Loung
ORCID ID
Contact details
95 Wen-Chaung Road
Taipei
111
Taiwan
M001015@ms.skh.org.tw
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
GnRH antagonist
Study hypothesis
Inhibition of premature luteinizing hormone (LH) surge by cetrorelix in letrozole/follicle-stimulating hormone (FSH) may benefit pregnancy rate.
Ethics approval
Approved by the Institutional Review Board of Shin Kong Wu Wo-Su Memorial Hospital on 22/08/2004; reference number: 94E-168
Study design
Randomized clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Couples with unexplained or mild male factor infetility
Intervention
Letrozole/FSH/cetrorelix versus Letrozoel/FSH
Intervention type
Drug
Phase
Not Specified
Drug names
Letrozole, cetrorelix
Primary outcome measures
Premature LH surge rate
Secondary outcome measures
1. Pregnancy rate
2. Serum levels of inhibin B and leptin
Overall trial start date
01/01/2005
Overall trial end date
31/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients of unexplained or mild male factor infertility
2. Body mass index (BMI) of 18-29 kg/m^2
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant exclusion criteria
1. Anovulatory patients
2. Age ≥38 years of age
3. Day 3 FSH ≥10 mIu/ml
4. Previous low ovarian response by other controlled ovarian hyperstimulation (COH) protocol e.g. clomiphene citrate (CC)/FSH or FSH
Recruitment start date
01/01/2005
Recruitment end date
31/08/2006
Locations
Countries of recruitment
Taiwan
Trial participating centre
95 Wen-Chaung Road
Taipei
111
Taiwan
Funders
Funder type
Hospital/treatment centre
Funder name
Shin Kong Wu Ho-Su Memorial Hospital Research Department
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
(SKH-8302-95-DR-21)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary