Condition category
Pregnancy and Childbirth
Date applied
02/07/2006
Date assigned
28/07/2006
Last edited
28/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Shin Kong Hospital Research Department (Taiwan)

Sponsor details

95 Wen-Chaung Road
Taipei
111
Taiwan

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes